Contact Nexalin: (714) 258-8004

CLINICAL TRIALS

Nexalin is a non-invasive, non-addictive medical device that is FDA-cleared for anxiety, depression and insomnia. Nexalin therapy has been used to treat 7,500 (internal estimate) patients for these conditions across the U.S. Its side effect profile is minimal and transient. Nexalin therapy is easily administered by a Nexalin Certified Technician.

There are numerous anecdotal reports that Nexalin therapy has also been effective in hard-to-treat patient populations across a much wider range of brain disorders. It has been suggested that Nexalin may stimulate and help restart the hypothalamus, so that the brain, in effect, heals itself. We believe we are now entering a new era of “brain health”.

Based on its attributes and positive clinical reports, we expect Nexalin to become the market leader among Transcranial Electrical Stimulation (TES) devices. It remains the only TES device offering alternating current for greater comfort and greater range. However, we need to provide evidence-based support to these anecdotal reports through clinical studies.

For these reasons, we believe it is advantageous to conduct a complete clinical trial program. Presently there are 9 studies taking place at over 15 locations consisting of over 850 participants. This program is currently underway and is expected to continue for the next few years. 


 

PROGRAMS

 

Alternative to ECT in treatment-resistant Major Depressive Disorder (MDD) patients

Location: Carrier Clinic, Belle Mead, NJ

Description: A double-blind, randomized controlled, crossover trial of 100 MDD patients who have been identified as candidates for ECT. Fifty patients will initially receive Nexalin therapy and 50 patients will be placed on sham devices. Non-responders will then cross-over. This study, performed under the guidance of University of Pennsylvania, is expected to be performed twice to confirm results. The clinical findings will then be presented to insurance companies, positioning Nexalin as the much less expensive alternative to ECT with a far better safety/tolerability profile.


Pilot Study on the management of anxiety, depression and insomnia in patients returning to sobriety

Location: Behavioral Health of the Palm Beaches, FL (BHOPB)

Description: Recovering in-patients at BHOPB were administered Nexalin therapy shortly after completing 48 hours of detoxification. This therapy was given in addition to their standard treatment. The unpublished outcomes of this small sample study appeared to indicate that Nexalin was an effective adjunctive therapy in the management of patients during early recovery. Patients also reported a lessening of cravings when Nexalin therapy was added. Additional clinical trials with larger sample sizes will be needed to confirm these results.


Management of anxiety, depression and insomnia in patients returning to sobriety

Location: 9 sites in NJ and PA including Carrier Clinic, High Focus, Advanced Health & Education and Liberation Behavioral Health

Description: A double-blind, randomized controlled trial of 100 patients who are returning to sobriety. In addition to the standard treatment, 50 patients will receive Nexalin therapy and 50 patients will receive sham treatment, following 48 hours of detoxification. Upon completion, all patients will have received a full course of therapy which is 15 x 40 minute treatment sessions over a period of 3-4 weeks. Patients will be treated initially at Carrier Clinic and then proceed to the other sites on an out-patient basis.


Efficacy, Dosing and longevity of Nexalin Therapy in the treatment of anxiety, depression and insomnia in patients returning to sobriety

Location: Integrity House, Newark, NJ

Description: This study is a continuation of the studies of patients returning to sobriety conducted at BHOPB and Carrier Clinic. It will contain a total of 550 patients and be divided into 3 distinct segments. All the regimens tested reflect the range of treatments that have anecdotal reports of effectiveness. Segment 1 Efficacy: A double-blind, randomized, controlled trial of 200 patients returning to sobriety. One hundred patients will receive Nexalin therapy and 100 patients will receive sham treatment, in addition to the standard treatment following 48 hours of detoxification. This will be the full course of Nexalin therapy of 15 x 40 minute treatment sessions over a 3-4 week period. This is accepted as the standard-of-care. Segment 2 Dosing: An additional 50 patients will be treated with the accepted standard-of-care of 15 x 40 minute treatment sessions over a 3-4 week period. Data from the 100 patients that received the active Nexalin treatment in Segment 1 Efficacy will be combined with this patient data for a total of 150 patients. An additional 150 patients will be treated with 3 x 40 minute treatment sessions per day for 5 days. An additional 150 patients will be treated with 3 x 40 minute treatment sessions per week for 5 weeks. Longevity: Each of the responders from the three treatment protocols will be tracked for up to one year.


Pilot study of NeuroStar TMS Therapy non-responders

Location: Confidential

Description: Patients undergoing NeuroStar TMS Therapy are typically hard to treat. It has been reported that roughly 60% of patients undergoing NeuroStar TMS Therapy fail to respond. Our hypothesis is that Nexalin will be an effective therapy for NeuroStar TMS Therapy non-responders. We will treat approximately 8-10 NeuroStar TMS Therapy non-responders with Nexalin.


Effects of Alternating Current, Trans-Cranial Stimulation on Pain Related Depression and Neuropathic Pain in Industrial Limb Injuries Including CRPS

Location: Atlanta

Description: A pilot study evaluating the effect of Nexalin treatment on a cohort of 10 patients that had neuropathic pain in their extremities as a result of trauma, was conducted. The preliminary results showed that Nexalin may be effective and a larger scale study is suggested.


A Retrospective Study on the addition of Nexalin therapy in patients returning to sobriety with Suboxone® therapy.

Location: Rhode Island

Description: A psychologist in Rhode Island, who is also employed as a clinical researcher at Harvard, took 40 patients being treated with Suboxone® and added Nexalin therapy. He reported increased benefits by adding Nexalin therapy to Suboxone. We are in the process of locating a comparable cohort of patients who have been treated with Suboxone alone.


 

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