Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

Highlights: This prospective study is one of the largest clinical trials in essential tremor to date. Study findings suggest that individualized non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction and improves quality of life for many essential tremor patients. Background: Two previous randomized, controlled, single-session trials demonstrated efficacy of non-invasive neuromodulation therapy targeting the median and radial nerves for reducing hand tremor. This current study evaluated efficacy and safety of the therapy over three months of repeated home use. Methods: This was a prospective, open-label, post-clearance, single-arm study with 263 patients enrolled across 26 sites. Patients were instructed to use the therapy twice daily for three months. Pre-specified co-primary endpoints were improvements on clinician-rated Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) and patient-rated Bain & Findley Activities of Daily Living (BF-ADL) dominant hand scores. Other endpoints included improvement in the tremor power detected by an accelerometer on the therapeutic device, Clinical and Patient Global Impression scores (CGI-I, PGI-I), and Quality of Life in Essential Tremor (QUEST) survey. Results: 205 patients completed the study. The co-primary endpoints were met (p≪0.0001), with 62% (TETRAS) and 68% (BF-ADL) of 'severe' or 'moderate' patients improving to 'mild' or 'slight'. Clinicians (CGI-I) reported improvement in 68% of patients, 60% (PGI-I) of patients reported improvement, and QUEST improved (p = 0.0019). Wrist-worn accelerometer recordings before and after 21,806 therapy sessions showed that 92% of patients improved, and 54% of patients experienced ≥50% improvement in tremor power. Device-related adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-related serious adverse events were reported. Discussion: This study suggests that non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction in many essential tremor patients.

Potential influences of complementary therapy on motor and non-motor complications in Parkinson's disease.

Nearly two-thirds of patients with Parkinson's disease (PD) use vitamins or nutritional supplements, and many more may use other complementary therapies, yet <50% of patients have discussed the use of these complementary therapies with a healthcare professional. Physicians should be aware of the complementary therapies their patients with PD are using, and the possible effects of these therapies on motor and non-motor symptoms. Complementary therapies, such as altered diet, dietary supplements, vitamin therapy, herbal supplements, caffeine, nicotine, exercise, physical therapy, massage therapy, melatonin, bright-light therapy and acupuncture, may all influence the symptoms of PD and/or the effectiveness of dopaminergic therapy. Preliminary evidence suggests complementary therapy also may influence non-motor symptoms of PD, such as respiratory disorders, gastrointestinal disorders, mood disorders, sleep and orthostatic hypotension. Whenever possible, clinicians should ensure that complementary therapy is used appropriately in PD patients without reducing the benefits of dopaminergic therapy.

Deep brain stimulation of the ventral intermediate nucleus of the thalamus in medically refractory orthostatic tremor: preliminary observations.

Orthostatic tremor (OT) is a disabling movement disorder associated with postural and gait impairment in the elderly. Medical therapy often yields insufficient benefit. We report the clinical and electrophysiological data on two patients with medication-refractory OT treated with deep brain stimulation of the ventral intermediate thalamic nucleus (Vim DBS). Patient 1 underwent bilateral deep brain stimulation (DBS) and Patient 2 unilateral Vim DBS following 28 and 30 years of disease duration, respectively. Both patients showed increased latency to symptom onset after rising from a seated position, improved tolerance for prolonged standing, and slower crescendo of tremor severity when remaining upright. Postoperative evaluation demonstrated decreased amplitude of electromyographic activity with persistence of well-defined oscillatory behavior showing strong coherence at 15 Hz between all muscles tested in the upper and lower limbs. Postural sway was unchanged. Clinical benefits have been sustained for over 18 months in Patient 1, and receded after 3 months in Patient 2. These findings support the consideration of bilateral Vim DBS implantation as a therapeutic option in patients with medically refractory OT. Further efficacy studies on chronic stimulation to disrupt the abnormal oscillatory activity in this disorder are warranted.

Use of nutritional supplements in Parkinson's disease patients.

The use of nutritional supplements has almost doubled in the elderly population in the United States (US) in the past decade. We evaluated the use of nutritional supplements in Parkinson's disease (PD) patients to determine the prevalence of their use and whether patients were aware of possible side effects and drug interactions in the supplements they were taking. Consecutively selected PD patients from an academic movement disorders center completed a 33-item questionnaire regarding their use of nutritional supplements. A total of 120 PD patients completed the questionnaire and were included in the data analysis (mean age +/- SD = 68.2 +/- 11.65 years, 67 [55.8%] men and 53 women). Seventy-six patients (63%) took nutritional supplements at the time of data collection. Vitamins were the most common nutritional supplements used, and vitamin E was the most commonly used vitamin. Thirty-six patients (47%) who took nutritional supplements consulted with their doctor before taking them, and only 4% of patients who took nutritional supplements were aware of possible side effects from their use. Twenty patients (16.7%) reported that they were currently taking nutritional supplements because of symptoms related to their Parkinson's disease. The vast majority of PD patients surveyed were not aware that nutritional supplements could cause adverse side effects. Less than half of the patients who took nutritional supplements consulted their physician before starting them. Greater awareness of nutritional supplement use in PD patients is warranted to avoid potentially harmful effects and drug interactions.

Essential tremor. Epidemiology, diagnosis, and treatment.

BACKGROUND: Essential tremor (ET) is the most common adult tremor disorder and is characterized by postural and kinetic tremor. Symptoms are typically progressive and potentially disabling, often forcing patients to change jobs or seek early retirement. Proper treatment is contingent on a correct diagnosis, and other possible causes of tremor must be excluded. REVIEW SUMMARY: Although primidone and propranolol have been regarded as the mainstays of pharmacologic therapy for ET, additional agents may be useful in reducing tremor. Surgical procedures are available that effectively ameliorate tremor that is refractory to medical management. This article reviews the epidemiology, pathophysiology, and treatment options for ET. CONCLUSIONS: Despite a range of treatment options currently available, further research is necessary to manage this syndrome most effectively. Double-blind, controlled trials are needed to determine whether primidone, propranolol, or a combination of these medications is superior in the initial management of ET. Other pharmacologic agents have shown potential to reduce tremor and should be investigated further. Additional studies are also needed to determine the best treatment of head and voice tremor with pharmacologic and surgical interventions. With proper treatment, tremor is sufficiently reduced in the majority of patients.

Management of essential tremor.

Essential tremor (ET) is the most prevalent tremor syndrome. It commonly affects the hands, head, voice, and other body parts. Appropriate management begins with correct diagnosis. Primidone and propranolol are the first-line medications for the treatment for ET, but several other medications may also provide benefit. In patients with medically refractory tremor, alternative therapies, including surgery or injections of botulinum toxin, may be considered.