A Randomized Preference Trial Comparing Cognitive-Behavioral Therapy and Yoga for the Treatment of Late-Life Worry: Examination of Impact on Depression, Generalized Anxiety, Fatigue, Pain, Social Participation, and Physical Function.

Background: Depression, generalized anxiety, fatigue, diminished physical function, reduced social participation, and pain are common for many older adults and negatively impact quality of life. The purpose of the overall trial was to compare the effects of cognitive-behavioral therapy (CBT) and yoga on late-life worry, anxiety, and sleep; and examine preference and selection effects on these outcomes. Objective: The present analyses compared effects of the 2 interventions on additional outcomes (depressive symptoms, generalized anxiety symptoms, fatigue, pain interference/intensity, physical function, social participation); and examined whether there are preference and selection effects for these treatments. Methods: A randomized preference trial of CBT and yoga was conducted in adults ≥60 years who scored ≥26 on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A), recruited from outpatient medical clinics, mailings, and advertisements. Cognitive-behavioral therapy consisted of 10 weekly telephone sessions. Yoga consisted of 20 bi-weekly group yoga classes. Participants were randomized to(1): a randomized controlled trial (RCT) of CBT or yoga (n = 250); or (2) a preference trial in which they selected their treatment (CBT or yoga; n = 250). Outcomes were measured at baseline and post-intervention. Results: Within the RCT, there were significant between-group differences for both pain interference and intensity. The pain interference score improved more for the CBT group compared with the yoga group [intervention effect of (mean (95% CI) = 2.5 (.5, 4.6), P = .02]. For the pain intensity score, the intervention effect also favored CBT over yoga [.7 (.2, 1.3), P < .01]. Depressive symptoms, generalized anxiety, and fatigue showed clinically meaningful within-group changes in both groups. There were no changes in or difference between physical function or social participation for either group. No preference or selection effects were found. Conclusion: Both CBT and yoga may be useful for older adults for improving psychological symptoms and fatigue. Cognitive-behavioral therapy may offer even greater benefit than yoga for decreasing pain.

Long-Term Effects of Cognitive-Behavioral Therapy and Yoga for Worried Older Adults.

OBJECTIVES: Cognitive-behavioral therapy (CBT) and yoga decrease worry and anxiety. There are no long-term data comparing CBT and yoga for worry, anxiety, and sleep in older adults. The impact of preference and selection on these outcomes is unknown. In this secondary data analysis, we compared long-term effects of CBT by telephone and yoga on worry, anxiety, sleep, depressive symptoms, fatigue, physical function, social participation, and pain; and examined preference and selection effects. DESIGN: In this randomized preference trial, participants (N = 500) were randomized to a: 1) randomized controlled trial (RCT) of CBT or yoga (n = 250); or 2) preference trial (selected CBT or yoga; n = 250). Outcomes were measured at baseline and Week 37. SETTING: Community. PARTICIPANTS: Community-dwelling older adults (age 60+ years). INTERVENTIONS: CBT (by telephone) and yoga (in-person group classes). MEASUREMENTS: Penn State Worry Questionnaire - Abbreviated (worry);1,2 Insomnia Severity Index (sleep);3 PROMIS Anxiety Short Form v1.0 (anxiety);4,5 Generalized Anxiety Disorder Screener (generalized anxiety);6,7 and PROMIS-29 (depression, fatigue, physical function, social participation, pain).8,9 RESULTS: Six months after intervention completion, CBT and yoga RCT participants reported sustained improvements from baseline in worry, anxiety, sleep, depressive symptoms, fatigue, and social participation (no significant between-group differences). Using data combined from the randomized and preference trials, there were no significant preference or selection effects. Long-term intervention effects were observed at clinically meaningful levels for most of the study outcomes. CONCLUSIONS: CBT and yoga both demonstrated maintained improvements from baseline on multiple outcomes six months after intervention completion in a large sample of older adults. TRIAL REGISTRATION: www. CLINICALTRIALS: gov Identifier NCT02968238.

Predictors of preference for cognitive-behavioral therapy (CBT) and yoga interventions among older adults.

The purpose of this study was to examine factors that influence a person's choice of cognitive-behavioral therapy (CBT) or yoga, the stability of these preferences, and the impact of preference on engagement and process measures. We conducted a randomized preference trial of CBT and yoga in 500 adults ≥60 years with symptoms of worry. Participants reported their intervention preference, strength of preference, and factors impacting preference. Engagement in the intervention (session completion and dropout rates) was assessed. Process measures included satisfaction with the intervention, therapeutic alliance, and intervention expectancy. Neither intervention preference (48% and 52% chose CBT and yoga, respectively) nor strength of preference differed significantly between the two preference trial groups. Intervention expectancies at baseline among those in the preference trial were approximately 4.5 units (40-point scale) higher for their preferred intervention (p < .0001 within each group). A principal component analysis of factors influencing preference identified three constructs. Using logistic regression, components focused on attitudes about CBT or yoga were predictive of ultimate preference (odds ratio = 11.5, 95% C.I.6.3-21.0 per 1SD difference in component 1 for choosing CBT; odds ratio = 7.8, 95% CI4.3-13.9 per 1SD difference in component 2 for choosing yoga). There were no significant differences between the randomized and preference trials on intervention adherence, completion of assessments, intervention satisfaction, or working alliance. Receiving a preferred treatment had no significant effects on intervention outcomes through participant engagement or process measures. When options are limited, providers may have confidence in offering the most readily available non-pharmacological treatments.

Ensuring Yoga Intervention Fidelity in a Randomized Preference Trial for the Treatment of Worry in Older Adults.

Introduction: Yoga for treatment of worry in older adults is an intervention that is especially likely to translate into real-world practice. Assessing treatment fidelity improves confidence that effective interventions can be consistently applied and allows researchers to explore if any null results for effectiveness are indeed the result of a lack of intervention efficacy or lack of proper intervention implementation. Methods: This study describes treatment fidelity of a yoga intervention in a randomized preference trial that compared cognitive-behavioral therapy (CBT) and yoga for the treatment of worry, anxiety, and sleep in worried older (≥60 years) adults. Established methods for assessing treatment fidelity of CBT guided the procedure for ensuring that the yoga intervention was delivered as intended. The yoga intervention consisted of 20, 75-min, in-person, group, gentle yoga classes held twice weekly. Results: Six female instructors (mean age = 64 years) taught 660 yoga classes that were videotaped. Ten percent of these classes, stratified by instructor, were randomly selected for review. The average adherence score for yoga instructors was 6.84 (range 4-8). The average competency scores were consistently high, with an average score of 7.24 (range 6-8). Teaching content not included in the protocol occurred in 26 (38.1%) sessions and decreased over time. Observed ratings of instructor adherence were significantly related to ratings of competency. Instructor adherence was also significantly associated with lower participant attendance, but not with any of the other process or outcome measures. Conclusions: The larger range found in adherence relative to competence scores demonstrated that teaching a yoga class according to a protocol requires different skills than competently teaching a yoga class in the community, and these skills improved with feedback. These results may foster dialog between the yoga research and practice communities. Clinical Trial Registration No.: NCT02968238.

Corrigendum to 'A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults' [Contemp. Clin. Trials Commun. 10 (2018) 169-176].

[This corrects the article DOI: 10.1016/j.conctc.2018.05.002.].

A closed-loop self-righting controller for seated balance in the coronal and diagonal planes following spinal cord injury.

Spinal cord injury (SCI) often results in loss of the ability to keep the trunk erect and stable while seated. Functional neuromuscular stimulation (FNS) can cause muscles paralyzed by SCI to contract and assist with trunk stability. We have extended the results of a previously reported threshold-based controller for restoring upright posture using FNS in the sagittal plane to more challenging displacements of the trunk in the coronal plane. The system was applied to five individuals with mid-thoracic or higher SCI, and in all cases the control system successfully restored upright sitting. The potential of the control system to maintain posture in forward-sideways (diagonal) directions was also tested in three of the subjects. In all cases, the controller successfully restored posture to erect. Clinically, these results imply that a simple, threshold based control scheme can restore upright sitting from forward, lateral or diagonal leaning without a chest strap; and that removal of barriers to upper extremity interaction with the surrounding environment could potentially allow objects to be more readily retrieved from around the wheelchair. Technical performance of the system was assessed in terms of three variables: response time, recovery time and percent maximum deviation from erect. Overall response and recovery times varied widely among subjects in the coronal plane (415±213 ms and 1381±883 ms, respectively) and in the diagonal planes (530±230 ms and 1800±820 ms, respectively). Average response time was significantly lower (p < 0.05) than the recovery time in all cases. The percent maximum deviation from erect was of the order of 40% or less for 9 out of 10 cases in the coronal plane and 5 out of 6 cases in diagonal directions.

Comparison of cognitive-behavioral therapy and yoga for the treatment of late-life worry: A randomized preference trial.

BACKGROUND: The purpose of this study was to compare the effects of cognitive-behavioral therapy (CBT) and yoga on late-life worry, anxiety, and sleep; and examine preference and selection effects on these outcomes. METHODS: A randomized preference trial of CBT and yoga was conducted in community-dwelling adults 60 years or older, who scored 26 or above on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A). CBT consisted of 10 weekly telephone sessions. Yoga consisted of 20 biweekly group yoga classes. The primary outcome was worry (PSWQ-A); the secondary outcomes were anxiety (PROMIS-Anxiety) and sleep (Insomnia Severity Index [ISI]). We examined both preference effects (average effect for those who received their preferred intervention [regardless of whether it was CBT or yoga] minus the average for those who did not receive their preferred intervention [regardless of the intervention]) and selection effect (which addresses the question of whether there is a benefit to getting to select one intervention over the other, and measures the effect on outcomes of self-selection to a specific intervention). RESULTS: Five hundred older adults were randomized to the randomized trial (125 each in CBT and yoga) or the preference trial (120 chose CBT; 130 chose yoga). In the randomized trial, the intervention effect of yoga compared with CBT adjusted for baseline psychotropic medication use, gender, and race was 1.6 (-0.2, 3.3), p = .08 for the PSWQ-A. Similar results were observed with PROMIS-Anxiety (adjusted intervention effect: 0.3 [-1.5, 2.2], p = .71). Participants randomized to CBT experienced a greater reduction in the ISI compared with yoga (adjusted intervention effect: 2.4 [1.2, 3.7], p < .01]). Estimated in the combined data set (N = 500), the preference and selection effects were not significant for the PSWQ-A, PROMIS-Anxiety, and ISI. Of the 52 adverse events, only two were possibly related to the intervention. None of the 26 serious adverse events were related to the study interventions. CONCLUSIONS: CBT and yoga were both effective at reducing late-life worry and anxiety. However, a greater impact was seen for CBT compared with yoga for improving sleep. Neither preference nor selection effects was found.

Effect of Losartan and Fish Oil on Plasma IL-6 and Mobility in Older Persons. The ENRGISE Pilot Randomized Clinical Trial.

BACKGROUND: Low-grade chronic inflammation, characterized by elevations in plasma Interleukin-6 (IL-6), is an independent risk factor of impaired mobility in older persons. Angiotensin receptor blockers and omega-3 polyunsaturated fatty acids (ω-3) may reduce IL-6 and may potentially improve physical function. To assess the main effects of the angiotensin receptor blocker losartan and ω-3 as fish oil on IL-6 and 400 m walking speed, we conducted the ENRGISE Pilot multicenter randomized clinical trial. METHODS: The ENRGISE Pilot enrolled participants between April 2016 and June 2017, who participated for 12 months. Participants were aged ≥70 years with mobility impairment, had IL-6 between 2.5 and 30 pg/mL, and were able to walk 400 m at baseline. Participants were randomized in three strata 2 × 2 factorial to: (i) losartan 50-100 mg/d or placebo (n = 43), (ii) fish oil 1,400-2,800 mg/d or placebo (n = 180), and (iii) with both (n = 66). RESULTS: Two hundred eighty-nine participants were randomized (mean age 78.3 years, 47.4% women, 17.0% black). There was no effect of losartan (difference of means = -0.065 ± 0.116 [SE], 95% confidence interval [CI]: -0.293-0.163, p = .58) or fish oil (-0.020 ± 0.077, 95% CI: -0.171-0.132, p = .80) on the log of IL-6. Similarly, there was no effect of losartan (-0.025 ± 0.026, 95% CI: -0.076-0.026, p = .34) or fish oil (0.010 ± 0.017, 95% CI: -0.025-0.044, p = .58) on walking speed (m/s). CONCLUSIONS: These results do not support the use of these interventions to prevent mobility loss in older adults at risk of disability with low-grade chronic inflammation. REGISTRATION: Clinicaltrials.gov NCT02676466.

A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults.

BACKGROUND: Worry is a common problem among older adults. Cognitive-behavioral therapy is the most studied nonpharmacological intervention and it has demonstrated efficacy in reducing late-life worry and anxiety. Although the evidence-base is smaller, yoga has been shown to reduce anxiety and stress. However, little is known about the relative effectiveness of these two nonpharmacological interventions. Further, the impact of patient preference on outcomes is unknown.Purpose: The purpose to this study is to compare the effectiveness of cognitive-behavioral therapy (CBT) with yoga for improving late-life worry, anxiety, and sleep. We will also examine the effects of preference and selection on outcomes, adherence, and attrition. METHODS: We are conducting a two-stage randomized preference trial comparing CBT and yoga for the reduction of worry in a sample of anxious older adults. Five hundred participants will be randomized to either the preference trial (participants choose the intervention; N = 250) or to the randomized trial (participants are randomized to one of the two interventions; N = 250) with equal probability. CBT consists of 10 telephone-based sessions with an accompanying workbook. Yoga consists of 10 weeks of group yoga classes (twice a week) that is modified for use with older adults. CONCLUSIONS: The study design is based on feedback from anxious older adults who wanted more nonpharmacological options for intervention as well as more input into the intervention they receive. It is the first head-to-head comparison of CBT and yoga for reducing late-life worry and anxiety. It will also provide information about how intervention preference affects outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02968238.

Association between circulating vitamin K1 and coronary calcium progression in community-dwelling adults: the Multi-Ethnic Study of Atherosclerosis.

BACKGROUND: Animal studies have shown that vitamin K treatment reduced vascular calcification, but human data are limited. OBJECTIVE: We determined the association between vitamin K status and coronary artery calcium (CAC) progression in the Multi-Ethnic Study of Atherosclerosis by using a case-cohort design. DESIGN: Serum phylloquinone (vitamin K1) was measured in 296 participants with extreme CAC progression and 561 randomly selected participants without extreme CAC progression; all subjects had baseline and follow-up CAC measures (mean follow-up: 2.5 y). A serum vitamin K1 concentration was considered low at <1.0 nmol/L (the distribution median). Outcomes were replicated by using post hoc per-protocol analyses of a vitamin K1 supplementation trial. RESULTS: The OR (95% CI) for extreme CAC progression for subjects with low serum vitamin K1 compared with subjects without extreme CAC progression was 1.34 (0.94, 1.90; NS) when adjusted for demographics and confounders. A significant interaction between low vitamin K1 and antihypertension medication use was detected (P = 0.016). Hypertension medication users with low serum vitamin K1 were more likely to have extreme CAC progression than were medication users without extreme CAC progression [OR (95% CI): 2.37 (1.38, 4.09)]. In replication, baseline antihypertensive medication users in the supplementation group had less CAC progression than did those in the control group [adjusted mean ± SEM of the 3-y CAC change was +5 ± 20 Agatston units (AU) in the vitamin K1 group (n = 40) and +44 ± 13 AU in the placebo group (n = 49); P < 0.01]. CONCLUSIONS: Although the point estimate of our primary analysis suggests low serum vitamin K1 is associated with greater CAC progression, the difference was NS. Low serum vitamin K1 was significantly associated with CAC progression in antihypertension medication users, which, to our knowledge, is a novel finding conditionally replicated by using an independent sample. Intervention trials are needed to determine whether improving serum vitamin K1 reduces CAC progression, especially in hypertensive individuals. This trial was registered at clinicaltrials.gov as NCT00183001.

Effects of intramuscular trunk stimulation on manual wheelchair propulsion mechanics in 6 subjects with spinal cord injury.

OBJECTIVE: To quantify the effects of stabilizing the paralyzed trunk and pelvis with electrical stimulation on manual wheelchair propulsion. DESIGN: Single-subject design case series with subjects acting as their own concurrent controls. SETTING: Hospital-based clinical biomechanics laboratory. PARTICIPANTS: Individuals (N=6; 4 men, 2 women; mean age ± SD, 46 ± 10.8y) who were long-time users (6.1 ± 3.9y) of implanted neuroprostheses for lower extremity function and had chronic (8.6 ± 2.8y) midcervical- or thoracic-level injuries (C6-T10). INTERVENTIONS: Continuous low-level stimulation to the hip (gluteus maximus, posterior adductor, or hamstrings) and trunk extensor (lumbar erector spinae and/or quadratus lumborum) muscles with implanted intramuscular electrodes. MAIN OUTCOME MEASURES: Pushrim kinetics (peak resultant force, fraction effective force), kinematics (cadence, stroke length, maximum forward lean), and peak shoulder moment at preferred speed over 10-m level surface; speed, pushrim kinetics, and subjective ratings of effort for level 100-m sprints and up a 30.5-m ramp of approximately 5% grade. RESULTS: Three of 5 subjects demonstrated reduced peak resultant pushrim forces (P≤.014) and improved efficiency (P≤.048) with stimulation during self-paced level propulsion. Peak sagittal shoulder moment remained unchanged in 3 subjects and increased in 2 others (P<.001). Maximal forward trunk lean also increased by 19% to 26% (P<.001) with stimulation in these 3 subjects. Stroke lengths were unchanged by stimulation in all subjects, and 2 showed extremely small (5%) but statistically significant increases in cadence (P≤.021). Performance measures for sprints and inclines were generally unchanged with stimulation; however, subjects consistently rated propulsion with stimulation to be easier for both surfaces. CONCLUSIONS: Stabilizing the pelvis and trunk with low levels of continuous electrical stimulation to the lumbar trunk and hip extensors can positively impact the mechanics of manual wheelchair propulsion and reduce both perceived and physical measures of effort.

Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury.

OBJECTIVE: To determine the stimulated strength of the paralyzed gluteal and paraspinal muscles and their effects on the seated function of individuals with paralysis. DESIGN: Case series with subjects acting as their own concurrent controls. SETTING: Hospital-based clinical biomechanics laboratory. PARTICIPANTS: Users (N=8) of implanted neuroprostheses for lower extremity function with low-cervical or thoracic level injuries. INTERVENTIONS: Dynamometry and digital motion capture both with and without stimulation to the hip and trunk muscles. MAIN OUTCOME MEASURES: Isometric trunk extension moment at 0°, 15°, and 30° of flexion; seated stability in terms of simulated isokinetic rowing; pelvic tilt, shoulder height, loaded and unloaded bimanual reaching to different heights, and subjective ratings of difficulty during unsupported sitting. RESULTS: Stimulation produced significant increases in mean trunk extension moment (9.2±9.5Nm, P<.001) and rowing force (27.4±23.1N, P<.012) over baseline volitional values. Similarly, stimulation induced positive changes in average pelvic tilt (16.7±15.7°) and shoulder height (2.2±2.5cm) during quiet sitting and bimanual reaching, and increased mean reach distance (5.5±6.6cm) over all subjects, target heights, and loading conditions. Subjects consistently rated tasks with stimulation easier than voluntary effort alone. CONCLUSIONS: In spite of considerable intersubject variability, stabilizing the paralyzed trunk with electrical stimulation can positively impact seated posture, extend forward reach, and allow exertion of larger forces on objects in the environment.

Use of the Case Western Reserve/Veterans Administration neuroprosthesis for exercise, standing and transfers by a paraplegic subject.

Functional electric stimulation (FES) is a technology that may allow patients with spinal cord injury (SCI) to transfer stand and walk. This paper reports upon the use of the Case Western Reserve Neuroprosthesis by a T6 ASIA B paraplegic subject. The subject was able to stand for two minutes and 50 seconds. He could walk 35 feet with a swing to gait. Measurement of energy consumption showed that metabolic demand was only 2.1 metabolic equivalent units. The factors that limited the use of the device that need to be improved to make the technology practical for household or community ambulation are speed (5.8 m/min) of ambulation and fatigue of the stimulated muscles.

Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study.

OBJECTIVES: To explore and quantify the physical and functional effects of stabilizing the torso with electrical stimulation of the paralyzed hip and trunk musculature after motor complete tetraplegia. DESIGN: Single-subject case study with repeated measures and concurrent controls. SETTING: Academic outpatient rehabilitation center. PARTICIPANTS: Forty-four-year-old man with C4 American Spinal Injury Association grade A tetraplegia 20 years postspinal cord injury. INTERVENTION: A surgically implanted multichannel pulse generator and intramuscular stimulating electrodes to activate lumbar erector spinae, quadratus lumborum, and gluteus maximus muscles bilaterally. MAIN OUTCOME MEASURES: Outcomes assessed with and without stimulation included (1) spinal alignment and pelvic orientation, (2) pulmonary function and ventilatory volumes, (3) forward bimanual reaching distance, (4) seated stability and resistance to externally applied disturbances, (5) maximal force and speed of rowing-like movements, and the ability to (6) independently return to an erect seated position from full forward or lateral flexion and (7) roll in bed without assistance. RESULTS: Stimulation improved spinal convexity and kyphosis by 26 degrees and 21 degrees , reduced posterior pelvic tilt by 11 degrees , increased forced expiratory volume and vital capacity by 10% and 22%, and improved forward reach by more than 7cm. Average resistance to sagittal disturbances increased by more than 40% (P<.002), and mean force exerted during underhanded pulling more than doubled (P=.014) with stimulation. Restoration of upright sitting in both sagittal and coronal planes and bed turning was made possible through appropriately timed activation of the hip and trunk muscles. CONCLUSIONS: A neuroprosthesis for controlling the paralyzed torso can positively impact spinal alignment, seated posture, pulmonary function, trunk stability, and reach. Stimulation of hip and trunk muscles can improve performance of activities of daily living as well as enable independent wheelchair and bed mobility.

Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation.

This paper describes the performance of a 16-channel implanted neuroprosthesis for standing and transfers after spinal cord injury including four-contact nerve-cuff electrodes stimulating the femoral nerve for knee extension. Responses of the nerve-cuffs were stable and standing times increased by 600% over time-matched values with a similar eight-channel neuroprosthesis utilizing muscle-based electrodes on vastus lateralis for knee extension.

Energy cost of the case Western reserve standing neuroprosthesis.

OBJECTIVE: To determine the oxygen consumption of a person with C7 American Spinal Injury Association (ASIA) grade B tetraplegia using the Case Western Reserve/Veterans Administration (CWRU/VA) standing neuroprosthesis. DESIGN: Measure the oxygen consumption and carbon dioxide production of a person with C7 ASIA grade B tetraplegia at rest, standing in the parallel bars with the CWRU/VA system on, ambulating in the parallel bars, and transferring from a wheelchair to a mat with the system on. SETTING: University medical center. PARTICIPANT: A 26-year-old man with C7 ASIA grade B tetraplegia. The subject was a recipient of the CWRU/VA standing neuroprosthesis. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Measurement of oxygen consumption and carbon dioxide production using a metabolic cart. RESULTS: Oxygen consumption of the subject was 1.22mL.kg(-1).min(-1) at rest. It was 4.7mL.kg(-1).min(-1) while standing in the parallel bars, 7.2mL.kg(-1).min(-1) while ambulating in the parallel bars, and 7.9mL.kg(-1).min(-1) when transferring from a wheelchair to a mat. CONCLUSIONS: Oxygen consumption of the subject when using the system is about 2 metabolic equivalent units, which is compatible with sustained use of the system for standing.

Phrenic nerve pacing in a tetraplegic patient via intramuscular diaphragm electrodes.

In patients with ventilator-dependent tetraplegia, phrenic nerve pacing (PNP) provides significant clinical advantages compared with mechanical ventilation. This technique however generally requires a thoracotomy with its associated risks and in-patient hospital stay and carries some risk of phrenic nerve injury. We have developed a method by which the phrenic nerves can be activated via intramuscular diaphragm electrodes. In one patient with ventilator-dependent tetraplegia, two intramuscular diaphragm electrodes were implanted into each hemidiaphragm near the phrenic nerve motor points via laparoscopic surgery. The motor points were identified employing a previously devised mapping technique. Because inspired volumes were suboptimal on the right, a second laparoscopic procedure was necessary to position electrodes near the anterior and posterior branches of the right phrenic nerve. During bilateral stimulation, inspired volume was 580 ml. After a reconditioning program of progressively increasing diaphragm pacing, maximum inspired volumes on the left and right hemidiaphragms increased significantly. Maximum combined bilateral stimulation was 1120 ml. Importantly, the patient has been able to comfortably tolerate full-time pacing. If confirmed in additional patients, PNP with intramuscular diaphragm electrodes via laparoscopic surgery may provide a less invasive and less costly alternative to conventional PNP.