A Randomized, Double-Blind, Trial of NexalinŽ vs. Placebo in Subjects with Early Parkinson's Disease
Rapid Response Innovation Awards, 2008
While the oral medications to treat PD are often quite effective in treating the physical symptoms (motor symptoms) such as tremor and stiffness, they may be associated with side effects such as sleepiness, nausea and dizziness and may be less effective at treating some of the non-motor symptoms such as depression, anxiety and insomnia. The Nexalin device is a portable device that generates electric current and is used to stimulate the brain through electrodes attached to the head. Preliminary evidence suggests that this device has effects on many chemical systems in the brain, including those primarily involved in PD (dopamine), mood (serotonin) and pain modulation (opiods) . Patients with PD who have used this device report benefit. More rigorous scientific study is warranted.
This study will enroll 24 participants. Half will receive active treatment and half will receive placebo stimulation. Subjects will attend the out patient clinic for treatment which will consist of ten 40 minute treatment sessions over two weeks. The treatment involves sitting in a recliner with the electrodes attached to the head while the stimulation is administered. Participants should not feel anything uncomfortable with the stimulation due to the low levels of current used. Following treatment, subjects will return to the clinic for five visits over 14 weeks to determine the response to treatment in terms of physical symptoms of PD as well as sleep, anxiety and depression.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
If this study has positive results, it may provide PD patients with a non-pharmacological alternative that is safe and easy to use and may benefit both motor symptoms and well as mood and sleep issues.
The hypothesis is that Nexlin Therapy will have a positive impact on PD, both in terms of physical motor symptoms like stiffness and tremor but also on anxiety, depression and sleep.
The study is close to completion and final results are being compiled. Of the 27 subjects who were screened for the study, 24 were randomized for treatment with one subject discontinuing treatment. At the time of this report, all 23 subjects in the study had completed randomized treatment and at least two follow-up visits; 16 subjects have completed the study with the remaining seven still actively participating. Sixteen of 23 subjects in the study are male (70%), and average age of the subjects is 70.0 years at baseline, living with Parkinson’s disease for 2.9 years. Three of the 23 subjects were not treated with drug therapy. The remainder was treated with levodopa (48%), rasagiline (30%), ropinirole (22%), pramipexole (21%), amantadine (13%) and/or selegiline (4%).
Director, Lonnie and Muhammad Ali Movement Disorder Center at Barrow Neurological Institute
Staff Physician at Sun Health Neuroscience Associates
Location: Phoenix, Arizona, United States