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1.
Neurosurgery ; 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38842320

ABSTRACT

BACKGROUND AND OBJECTIVES: Ventriculo-peritoneal shunt procedures can improve idiopathic normal pressure hydrocephalus (iNPH) symptoms. However, there are no automated methods that quantify the presurgery and postsurgery changes in the ventricular volume for computed tomography scans. Hence, the main goal of this research was to quantify longitudinal changes in the ventricular volume and its correlation with clinical improvement in iNPH symptoms. Furthermore, our objective was to develop an end-to-end graphical interface where surgeons can directly drag-drop a brain scan for quantified analysis. METHODS: A total of 15 patients with 47 longitudinal computed tomography scans were taken before and after shunt surgery. Postoperative scans were collected between 1 and 45 months. We use a UNet-based model to develop a fully automated metric. Center slices of the scan that are most representative (80%) of the ventricular volume of the brain are used. Clinical symptoms of gait, balance, cognition, and bladder continence are studied with respect to the proposed metric. RESULTS: Fifteen patients with iNPH demonstrate a decrease in ventricular volume (as shown by our metric) postsurgery and a concurrent clinical improvement in their iNPH symptomatology. The decrease in postoperative central ventricular volume varied between 6 cc and 33 cc (mean: 20, SD: 9) among patients who experienced improvements in gait, bladder continence, and cognition. Two patients who showed improvement in only one or two of these symptoms had <4 cc of cerebrospinal fluid drained. Our artificial intelligence-based metric and the graphical user interface facilitate this quantified analysis. CONCLUSION: Proposed metric quantifies changes in ventricular volume before and after shunt surgery for patients with iNPH, serving as an automated and effective radiographic marker for a functioning shunt in a patient with iNPH.

2.
Am Surg ; 90(6): 1570-1576, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38592191

ABSTRACT

BACKGROUND: There lacks rapid standardized bedside testing to screen cognitive deficits following mild traumatic brain injury (mTBI). Immediate Post-Concussion Assessment & Cognitive Testing-Quick Test (ImPACT-QT) is an abbreviated-iPad form of computerized cognitive testing. The aim of this study is to test ImPACT-QT utility in inpatient settings. We hypothesize ImPACT-QT is feasible in the acute trauma setting. METHOD: Trauma patients ages 12-70 were administered ImPACT-QT (09/2022-09/2023). Encephalopathic/medically unstable patients were excluded. Mild traumatic brain injury was defined as documented-head trauma with loss-of-consciousness <30 minutes and arrival Glasgow Coma Scale 13-15. Patients answered Likert-scale surveys. Bivariate analyses compared demographics, attention, motor speed, and memory scores between mTBI and non-TBI controls. Multivariable logistic regression assessed memory score as a predictor of mTBI diagnosis. RESULTS: Of 233 patients evaluated (36 years [IQR 23-50], 71% [166/233] female), 179 (76%) were mTBI patients. For all patients, mean test-time was 9.3 ± 2 minutes with 93% (73/76) finding the test "easy to understand." Mild traumatic brain injury patients than non-TBI control had lower memory scores (25 [IQR 7-100] vs 43 [26-100], P = .001) while attention (5 [1-23] vs 11 [1-32]) and motor score (14 [3-28] vs 13 [4-32]) showed no significant differences. Multivariable-regression (adjustment: age, sex, race, education level, ISS, and time to test) demonstrated memory score predicted mTBI positive status (OR .96, CI .94-.98, P = .004). DISCUSSION: Immediate Post-Concussion Assessment & Cognitive Testing-Quick Test is feasible in trauma patients. Preliminary findings suggest acute mTBIs have lower memory but not attention/motor scores vs non-TBI trauma controls.


Subject(s)
Brain Concussion , Neuropsychological Tests , Trauma Centers , Humans , Female , Male , Adult , Brain Concussion/diagnosis , Brain Concussion/complications , Middle Aged , Adolescent , Young Adult , Computers, Handheld , Aged , Cognitive Dysfunction/diagnosis , Cognitive Dysfunction/etiology , Child , Point-of-Care Testing , Glasgow Coma Scale
3.
World Neurosurg ; 2024 Apr 27.
Article in English | MEDLINE | ID: mdl-38679378

ABSTRACT

OBJECTIVE: The local effects of an intracerebral hemorrhage (ICH) on surrounding brain tissue can be detected bedside using multimodal brain monitoring techniques. The aim of this study is to design a gradient boosting regression model using the R package boostmtree with the ability to predict lactate-pyruvate ratio measurements in ICH. METHODS: We performed a retrospective analysis of 6 spontaneous ICH and 6 traumatic ICH patients who underwent surgical removal of the clot with microdialysis catheters placed in the perihematomal zone. Predictors of glucose, lactate, pyruvate, age, sex, diagnosis, and operation status were used to design our model. RESULTS: In a holdout analysis, the model forecasted lactate-pyruvate ratio trends in a representative in-sample testing set. We anticipate that boostmtree could be applied to designs of similar regression models to analyze trends in other multimodal monitoring features across other types of acute brain injury. CONCLUSIONS: The model successfully predicted hourly lactate-pyruvate ratios in spontaneous ICH and traumatic ICH cases after the hemorrhage evacuation and displayed significantly better performance than linear models. Our results suggest that boostmtree may be a powerful tool in developing more advanced mathematical models to assess other multimodal monitoring parameters for cases in which the perihematomal environment is monitored.

4.
Surg Neurol Int ; 14: 395, 2023.
Article in English | MEDLINE | ID: mdl-38053714

ABSTRACT

Background: Cerebral microdialysis (CMD) is an FDA-approved multimodal invasive monitoring technique that provides local brain metabolism measurements through continuous interstitial brain fluid sampling at the bedside. The past applications in traumatic brain injury and subarachnoid hemorrhage show that acute brain injury (ABI) can lead to a metabolic crisis reflected by changes in cerebral glucose, pyruvate, and lactate. However, limited literature exists on CMD in spontaneous intracerebral hemorrhage (ICH). Case Description: A 45-year-old woman presented with a Glasgow Coma Scale of 8T and left frontal ICH with a 6 mm midline shift. She underwent craniotomy and ICH evacuation. Intraoperatively, CMD, brain tissue oxygenation (PbtO2), intracranial pressure (ICP), and cerebral blood flow (CBF) catheters were placed, targeted toward the peri-hematoma region. Postoperatively, ICP was normal; however, PbtO2, CBF, glucose, and lactate/ pyruvate ratio were abnormal. Due to concern for the metabolic crisis, poor examination, and hydrocephalus on computed tomography of the head (CTH), she underwent external ventricular drainage (EVD). Post-EVD, all parameters normalized (P < 0.05 on Student's t-test). Monitors were removed, and she was discharged to a nursing facility with a modified Rankin scale of 4. Conclusion: Here, we demonstrate the safe implementation of CMD in ICH and the use of CMD in tandem with PbtO2/ICP/CBF to guide treatment in ICH. Despite a normal ICP, numerous cerebral metabolic derangements existed and improved after cerebrospinal fluid diversion. A normal ICP may not reflect underlying metabolic-substrate demands of the brain during ABI. CMD and PbtO2/CBF monitoring augment traditional ICP monitoring in brain injury. Further prospective studies will be needed to understand further the interplay between ICP, PbtO2, CBF, and CMD values in ABI.

5.
7.
World Neurosurg ; 164: e481-e491, 2022 08.
Article in English | MEDLINE | ID: mdl-35552037

ABSTRACT

BACKGROUND: In a flipped classroom, students learn lecture material before class and then participate in active learning during in-person sessions. This study examines preferences for flipped classroom activities during a neurosurgery presentation on traumatic brain injury. METHODS: Two hundred twenty-five third- and fourth-year medical students on their core neurology rotation watched an online podcast about traumatic brain injury before meeting for in-person, active learning activities with a neurological surgeon. Before and after the class, students were given rank-based surveys with an optional section for comments. The initial survey assessed preference for specific active learning activities, and the final survey assessed satisfaction with the experience. The students also answered an online 20-question postlecture test as part of the standard neurology class assessment. RESULTS: Every student scored over 90% on the postlecture test. Of the 81 students who answered the first survey, most students (83.95%) strongly preferred or preferred case scenarios with group discussion. The average Likert score for case scenario preference (4.37/5) was significantly higher than the score for all other activities (P < 0.05). Of the 207 students who answered the second survey, 80.19% of students reported that they would probably or definitely like to see more flipped classroom activities. CONCLUSIONS: Medical students highly preferred case scenarios because according to their comments, this method was relevant to real-life situations and led to higher information retention. This information suggests that the flipped classroom model for neurosurgical-based lectures is preferred, is beneficial, and should incorporate case scenarios. This methodology may also apply to neurosurgical residency training.


Subject(s)
Brain Injuries, Traumatic , Neurosurgery , Students, Medical , Curriculum , Humans , Problem-Based Learning/methods , Surveys and Questionnaires
8.
Laryngoscope ; 132(10): 1939-1945, 2022 10.
Article in English | MEDLINE | ID: mdl-35543275

ABSTRACT

OBJECTIVE: Pain control is an important topic that has not been extensively studied in patients undergoing endoscopic skull base surgery (ESBS). The purpose of this study is to identify opioid requirements after ESBS and the risk factors predictive of increased use. METHODS: This study was a retrospective review of all patients undergoing ESBS at a tertiary academic skull base surgery program between July 2018 and August 2020. The primary outcome variable was total morphine equivalent dose (MED) requirements after surgery, calculated as the sum of all morphine milligram equivalents over a 24-h period, and summated across the duration of each participant's hospital course. RESULTS: 94 patients were included in this review. Average daily MED requirements were 14.00 ± 6.79 mg. Average total MED requirements were 83.78 ± 92.99 mg during hospitalization. Average length of stay (LOS) was 5.71 ± 4.42 days, with 22 (23.4%) patients not requiring opioid use upon discharge. On multivariate analysis, female sex (ß = 49.62; 95% CI [13.53, 85.71], p = 0.008), nasoseptal flap (NSF) reconstruction (ß = 49.56; 95% CI [13.51, 85.61], p = 0.008) and LOS (ß = 4.02; 95% CI [0.001, 8.04], p = 0.050) were independently associated with higher total MED requirements. CONCLUSIONS: We report average total MED requirements of 83.78 mg after ESBS, with female sex, intraoperative use of an NSF, and increased LOS as predictors of higher MED use. This data indicates a subset of patients who may benefit from more aggressive pain control strategies upfront, including consideration of non-opioid, multimodal pain regimens. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:1939-1945, 2022.


Subject(s)
Analgesics, Opioid , Neurosurgical Procedures , Analgesics, Opioid/therapeutic use , Female , Humans , Morphine Derivatives , Pain , Pain, Postoperative/drug therapy , Pain, Postoperative/etiology , Retrospective Studies , Skull Base/surgery
9.
Neurocrit Care ; 37(1): 246-254, 2022 08.
Article in English | MEDLINE | ID: mdl-35445934

ABSTRACT

BACKGROUND: Spontaneous intracerebral hemorrhage is a potentially devastating cause of brain injury, often occurring secondary to hypertension. Contrast extravasation on computed tomography angiography (CTA), known as the spot sign, has been shown to predict hematoma expansion and worse outcomes. Although hypertension has been associated with an increased rate of the spot sign being present, the relationship between spot sign and blood pressure has not been fully explored. METHODS: We retrospectively analyzed data from 134 patients (40 women and 94 men, mean age 62.3 ± 15.73 years) presenting to a tertiary academic medical center with spontaneous supratentorial subcortical intracerebral hemorrhage from 1/1/2018 to 1/4/2021. RESULTS: A spot sign was demonstrated in images of 18 patients (13.43%) and correlated with a higher intracerebral hemorrhage score (2.61 ± 1.42 vs. 1.31 ± 1.25, p = 0.002), larger hematoma volume (53.49cm3 ± 32.08 vs. 23.45cm3 ± 25.65, p = 0.001), lower Glasgow Coma Scale on arrival (9.06 ± 4.56 vs. 11.74 ± 3.65, p = 0.027), increased risk of hematoma expansion (16.67% vs. 5.26%, p = 0.042), and need for surgical intervention (66.67% vs. 15.52%, p < 0.001). We did not see a correlation with age, sex, or underlying comorbidities. The presence of spot sign correlated with higher modified Rankin scores at discharge (4.94 ± 1.00 vs. 3.92 ± 1.64, p < 0.001). We saw significantly higher systolic blood pressure at the time of CTA in patients with a spot sign (184 mm Hg ± 43.11 vs. 153 mm Hg ± 36.99, p = 0.009) and the highest recorded blood pressure (p = 0.019), although not blood pressure on arrival (p = 0.081). Performing CTA early in the process of blood pressure lowering was associated with a spot sign (p < 0.001). CONCLUSIONS: The presence of spot sign correlates with larger hematomas, worse outcomes, and increased surgical intervention. There is a significant association between spot sign and systolic blood pressure at the time of CTA, with the highest systolic blood pressure being recorded prior to CTA. Although the role of intensive blood pressure management in spontaneous intracerebral hemorrhage remains a subject of debate, patients with a spot sign may be a subgroup that could benefit from this.


Subject(s)
Cerebral Hemorrhage , Hypertension , Aged , Cerebral Angiography/adverse effects , Cerebral Hemorrhage/complications , Computed Tomography Angiography/adverse effects , Female , Hematoma/complications , Humans , Hypertension/complications , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies
11.
World Neurosurg ; 160: e344-e352, 2022 04.
Article in English | MEDLINE | ID: mdl-35026454

ABSTRACT

INTRODUCTION: Manual pupillary assessments are an integral part of the neurologic evaluation in critically ill patients. Automated pupillometry provides reliable, consistent, and accurate measurement of the light response. We established a computer interface that allows for direct download of pupillometer information to our hospital electronic medical record (EMR). Here, we report our single-center experience. METHODS: An interface allowing direct download of pupillometer data to our EMR was developed. We then performed a prospective study using an electronic survey distributed to nurses that used pupillometers in 2015, 2018, and 2020 using a 5-point Likert-style format to evaluate the acceptance of this implementation. RESULTS: In 2015, 22 nurses were surveyed, with 50% of the respondents citing lack of pupillometers and 41% citing the labor intensity associated with data entry as the reason for the reluctance to use the pupillometer. The number of nurse responses in 2018 increased to 123, with 78% of nurses finding that the direct download to hospital EMR improved the efficiency of their neurologic exams. In 2020, 108 nurses responded with similar responses to those in 2018. We added 3 additional questions regarding utility of the pupillometer during the COVID-19 pandemic. Fifty-eight percent of nurses were reassured of the neurologic exam when using the pupillometer in lieu of a full exam to limit infectious exposure. CONCLUSIONS: This is the first report of the implementation of a direct interface to download pupillometer data to the EMR. The positive effect on nursing workflow and documentation of pupillary findings is discussed.


Subject(s)
COVID-19 , Electronic Health Records , Hospitals , Humans , Pandemics , Prospective Studies , Reflex, Pupillary/physiology
12.
Oper Neurosurg (Hagerstown) ; 22(3): 123-130, 2022 03 01.
Article in English | MEDLINE | ID: mdl-35030111

ABSTRACT

BACKGROUND: Spontaneous intracerebral hemorrhage (sICH) is associated with high morbidity and mortality, and the role of surgery is uncertain. Spot sign on computed tomography angiography (CTA) has previously been seen as a contraindication for minimally invasive techniques. OBJECTIVE: To demonstrate the use of minimally invasive parafascicular surgery (MIPS) for early evacuation of sICH in patients with spot sign on CTA. METHODS: Retrospective review of patients presenting to a US tertiary academic medical center from 2018 to 2020 with sICH and CTA spot sign who were treated with MIPS within 6 h of arrival. RESULTS: Seven patients (6 men and 1 woman, mean age 54.4 yr) were included in this study. There was a significant decrease between preoperative and postoperative intracerebral hemorrhage volumes (75.03 ± 39.00 cm3 vs 19.48 ± 17.81 cm3, P = .005) and intracerebral hemorrhage score (3.1 ± 0.9 vs 1.9 ± 0.9, P = .020). The mean time from arrival to surgery was 3.72 h (±1.22 h). The mean percentage of hematoma evacuation was 73.78% (±21.11%). The in-hospital mortality was 14.29%, and the mean modified Rankin score at discharge was 4.6 (±1.3). No complications related to the surgery were encountered in any of the cases, with no abnormal intraoperative bleeding and no pathology demonstrating occult vascular lesion. CONCLUSION: Early intervention with MIPS appears to be a safe and effective means of hematoma evacuation despite the presence of CTA spot sign, and this finding should not delay early intervention when indicated. Intraoperative hemostasis may be facilitated by the direct visualization provided by a tubular retractor system.


Subject(s)
Computed Tomography Angiography , Hematoma , Cerebral Angiography/methods , Cerebral Hemorrhage/diagnostic imaging , Cerebral Hemorrhage/surgery , Female , Humans , Male , Middle Aged , Postoperative Hemorrhage , Tomography, X-Ray Computed/methods
14.
Laryngoscope ; 132(4): 761-768, 2022 04.
Article in English | MEDLINE | ID: mdl-34694008

ABSTRACT

OBJECTIVES/HYPOTHESIS: The objective of this study is to evaluate the impact of patient and surgical factors, including approach and reconstruction type, on postoperative nausea and vomiting episodes following endoscopic skull base surgery. STUDY DESIGN: Retrospective review. METHODS: We performed a retrospective chart review from July 2018 to August 2020 of 99 consecutive patients undergoing endoscopic skull base surgery at a tertiary academic skull base surgery program. All patients were treated with a standardized postoperative protocol consisting of scheduled ondansetron, along with promethazine and scopolamine for breakthrough nausea and vomiting episodes. Cumulative nausea and vomiting episodes throughout hospital stay were recorded for each patient. RESULTS: Of the 99 patients identified, the mean number of nausea and vomiting episodes per patient were 0.4 ± 1.2 and 0.3 ± 0.7, respectively. Female sex (ß = .65, P = .034) and extended surgical approach (ß = .90, P = .027) were associated with increased risk for postoperative nausea. Furthermore, female sex (ß = .44, P = .018), cavernous sinus dissection (ß = .52, P = .002), and extended approach (ß = .79, P = .025) significantly increased odds of postoperative vomiting episodes. There was no association between total operative time or total postoperative opioid dose and nausea and vomiting episodes (all Ps > .05). Neither increased nausea nor vomiting episodes significantly increased odds of prolonged hospitalization (P = .105 and .164, respectively). CONCLUSION: This report highlights novel risk factors for patients undergoing endoscopic skull base surgery. Upfront standing antiemetic therapy may be considered when treating patients with independent predictors of postoperative nausea and vomiting, including female sex, cavernous sinus dissection, and extended surgical approach. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:761-768, 2022.


Subject(s)
Antiemetics , Postoperative Nausea and Vomiting , Antiemetics/therapeutic use , Double-Blind Method , Female , Humans , Ondansetron/adverse effects , Ondansetron/therapeutic use , Postoperative Nausea and Vomiting/epidemiology , Postoperative Nausea and Vomiting/etiology , Retrospective Studies , Skull Base , Vomiting/chemically induced
15.
J Neurosurg ; 136(1): 40-44, 2022 01 01.
Article in English | MEDLINE | ID: mdl-34243148

ABSTRACT

OBJECTIVE: Elective surgical cases generally have lower costs, higher profit margins, and better outcomes than nonelective cases. Investigating the differences in cost and profit between elective and nonelective cases would help hospitals in planning strategies to withstand financial losses due to potential pandemics. The authors sought to evaluate the exact cost and profit margin differences between elective and nonelective supratentorial tumor resections at a single institution. METHODS: The authors collected economic analysis data in all patients who underwent supratentorial tumor resection at their institution between January 2014 and December 2018. The patients were grouped into elective and nonelective cases. Propensity score matching was used to adjust for heterogeneity of baseline characteristics between the two groups. RESULTS: There were 143 elective cases and 232 nonelective cases over the 5 years. Patients in the majority of elective cases had private insurance and in the majority of nonelective cases the patients had Medicare/Medicaid (p < 0.01). The total charges were significantly lower for elective cases ($168,800.12) compared to nonelective cases ($254,839.30, p < 0.01). The profit margins were almost 6 times higher for elective than for nonelective cases ($13,025.28 vs $2,128.01, p = 0.04). After propensity score matching, there was still a significant difference between total charges and total cost. CONCLUSIONS: Elective supratentorial tumor resections were associated with significantly lower costs with shorter lengths of stay while also being roughly 6 times more profitable than nonelective cases. These findings may help future planning for hospital strategies to survive financial losses during future pandemics that require widespread cancellation of elective cases.


Subject(s)
Brain Neoplasms/economics , Brain Neoplasms/surgery , Costs and Cost Analysis/trends , Elective Surgical Procedures/economics , Elective Surgical Procedures/trends , Propensity Score , Female , Humans , Insurance Coverage/economics , Insurance Coverage/trends , Length of Stay/economics , Length of Stay/trends , Male , Middle Aged , Postoperative Complications/economics , Postoperative Complications/prevention & control , Retrospective Studies , Risk Factors
16.
Front Neurol ; 13: 1041952, 2022.
Article in English | MEDLINE | ID: mdl-36698903

ABSTRACT

Background: Cerebral microdialysis enables monitoring of brain metabolism and can be an important part of multimodal monitoring strategies in a variety of brain injuries. Microdialysis catheters can be placed in brain parenchyma through a burr hole, a cranial bolt, or directly at the time of an open craniotomy or craniectomy. The location of catheters in relation to brain pathology is important to the interpretation of data and guidance of interventions. Methods: Here we retrospectively review the use of cerebral microdialysis at a US Regional Medical Center between March 2018 and February 2022 and provide detailed descriptions and technical nuances of the different methods to place microdialysis catheters. Results: Eighty two unique microdialysis catheters were utilized in 52 patients. 35 (42.68%) were placed via a quad-lumen bolt and 47 (57.32%) were placed through craniotomies. 27 catheters (32.93%) were placed in a perilesional location, 50 (60.98%) were located in healthy tissue, and 6 (7.32%) were mispositioned. No significant difference was seen between placement by bolt or craniotomy in regard to perilesional location, mispositioning, or complications. Conclusion: With careful planning and thoughtful execution, cerebral microdialysis catheters can be successfully placed though a variety of strategies to optimize and individualize brain monitoring in different clinical settings. This paper provides a detailed guide for the various methods of catheter placement to help providers begin or expand their use of cerebral microdialysis.

17.
Front Neurol ; 12: 660885, 2021.
Article in English | MEDLINE | ID: mdl-34025564

ABSTRACT

Background: Chronic subdural hematomas (cSDH) are increasingly prevalent worldwide with the increased aging population and anticoagulant use. Different surgical, medical, and endovascular treatments have had varying success rates. Primary neurosurgical interventions include burr hole drainage of the cSDH and mini-craniotomies/craniotomies with or without fenestration of the inner membrane. A key assessment of the success or failure of cSDH treatments has been symptomatic recurrence rates which have historically ranged from 5 to 30%. Pre-operative prediction of the inner subdural membrane by CT scan was used to guide our decision to perform mini-craniotomies. Release of the inner membrane facilitates the expansion of the brain and likely improves glymphatic flow. Methods: Consecutive mini-craniotomies (N = 34) for cSDH evacuation performed by a single neurosurgeon at a quaternary academic medical center/Level I trauma center from July 2018-September 2020 were retrospectively reviewed. Patient characteristics [age, gender, presenting GCS, GOS, initial CTs noting the inner subdural membrane, midline shift (MLS), cSDH width, inner membrane fenestration, cSDH recurrence, post-operative seizures, infections, length of stay] were extracted from the EMR. Results: Twenty nine patients had mini-craniotomies as primary treatment of the cSDH. Mean age = 68.9 ± 19.7 years (range 22-102), mean pre-operative GCS = 14.5 ± 1.1, mean MLS = 6.75 ± 4.2 mm, and mean maximum thickness of cSDH = 17.7 ± 6.0 mm. Twenty four were unilateral, five bilateral, 34 total craniotomies were performed. Thirty three had inner membrane signs on pre-operative head CTs and an inner subdural membrane was fenestrated in all cases except for the one craniotomy that didn't show these characteristic CT findings. Mean operating time = 79.5 ± 26.0 min. Radiographic and clinical improvement occurred in all patients. Mean improvement in MLS = 3.85 ± 2.69. There were no symptomatic recurrences, re-operations, surgical site infections, or deaths during the 6 months of follow-up. One patient was treated for post-operative seizures with AEDs for 6 months. Conclusion: Pre-operative CT scans demonstrating inner subdural membranes may guide one to target the treatment to allow release of this tension band. Mini-craniotomy with careful fenestration of the inner membrane is very effective for this. Brain re-expansion and re-establishment of normal brain interstitial flow may be important in long term outcomes with cSDH and may be related to the recent interests in brain glymphatics and dural lymphatics.

18.
Neurology ; 2021 Jan 04.
Article in English | MEDLINE | ID: mdl-33397772

ABSTRACT

OBJECTIVE: To determine if chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by implantation of allogeneic modified bone marrow-derived mesenchymal stromal/stem cells (SB623). METHODS: This 6-month interim analysis of the 1-year double-blind, randomized, surgical sham-controlled, phase 2 STEMTRA trial (NCT02416492) evaluated safety and efficacy of the stereotactic intracranial implantation of SB623 in patients with stable chronic motor deficits secondary to TBI. Patients in this multi-center trial (N = 63) underwent randomization in a 1:1:1:1 ratio to 2.5 × 106, 5.0 × 106, 10 × 106 SB623 cells or control. Safety was assessed in patients who underwent surgery (N = 61), and efficacy in the modified intent-to-treat population of randomized patients who underwent surgery (N = 61; SB623 = 46, control = 15). RESULTS: The primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale score at 6 months for SB623-treated patients was achieved. SB623-treated patients improved by (LS mean [SE]) +8.3 (1.4) vs +2.3 (2.5) for control at 6 months, the LS mean difference was 6.0 (95% CI: 0.3-11.8); p = 0.040. Secondary efficacy endpoints improved from baseline, but were not statistically significant vs control at 6 months. There were no dose-limiting toxicities or deaths, and 100% of SB623-treated patients experienced treatment-emergent adverse events vs 93.3% of control patients (p = 0.25). CONCLUSIONS: SB623 cell implantation appeared to be safe and well tolerated, and patients implanted with SB623 experienced significant improvement from baseline motor status at 6 months compared to controls. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.

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