Research
The Fisher Wallace Stimulator® is the most highly researched wearable brain stimulation device on the market. We have conducted research on biomarkers (increased serotonin, lowered cortisol), depression, anxiety, insomnia, patient safety (including pediatric), Parkinson’s disease, and the treatment of substance use disorder patients - in total involving more than 1100 participants.
Depression research conducted at Mount Sinai Beth Israel Hospital
A study conducted at Mount Sinai Beth Israel Hospital and published in the Journal of Nervous and Mental Disease concluded that Bipolar II Depression (BD II) patients who received daily treatment with the Fisher Wallace Stimulator® experienced significant reduction in self-reported depression symptoms compared to patients using a placebo device. No serious side effects or adverse events such as hypomania were experienced by patients in the study.
Research conducted on treating Generalized Anxiety Disorder
Fisher Wallace Labs examined the safety and effectiveness of the Fisher Wallace Stimulator for the treatment of Generalized Anxiety Disorder (GAD) using a double blind randomized controlled trial (RCT) conducted during the COVID-19 pandemic. This 8-week study enrolled 325 subjects. There were no serious adverse events. 62.5% of treated subjects with Moderate GAD reported at least a 50% improvement in their Beck Anxiety Inventory score compared to 38.2% of subjects in the placebo arm, an exploratory outcome. Results were submitted to the FDA to support the company's anxiety indication in March, 2021.
Insomnia research conducted at University of Illinois at Chicago
We conducted our most recent insomnia study during the height of the pandemic in 2020 when many patients were in lockdown. Our device increased total sleep time (TST) in active device participants by 25.8 minutes, whereas participants using a placebo device experienced a decrease in total sleep time of 16.5 minutes - a total difference between active and placebo of 42.4 minutes.
A study on the physiological and therapeutic effects of high frequency electrical pulses
Human subjects were stimulated using the LISS Cranial Stimulator (the name of the Fisher Wallace Stimulator prior to a rebranding). The study showed significant increases in levels of CSF serotonin and beta endorphin were reorded post stimulation. There were also elevations in the levels of plasma serotonin, beta endorphin, GABA and DHEA together with diminished levels of cortisol and tryptophan.
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A study on treating patients with substance abuse dependence
This report presents findings from a retrospective chart review examining the impact of cranial electrotherapy stimulation (CES) on the retention rates of newly abstinent substance dependent individuals in community-based residential treatment. Clients who received CES sessions during their first month in residential treatment exhibited better retention rates during the first 30 days, as well as at 60 and 90 days in treatment, compared to clients who did not receive CES. Sessions were well tolerated and clients reported improved sleep and reduced stress.
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The impact of cranial electrical stimulation on neurochemical levels
10 patients had cerebrospinal fluid and plasma collected before and after undergoing 20 minutes of cranial electrical stimulation (CES) with a cranial electrical stimulator. Data analysis showed that cerebrospinal fluid and plasma levels of serotonin and beta-endorphin increased significantly, and melatonin increased significantly in plasma. This hypothalamic modulation may explain the reported antidepressant effect of CES.
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A study on the safety of our technology
We tested the safety of the Fisher Wallace Stimulator applied to seven children (age range 2.5 to 7.5 years) with a confirmed diagnosis of cerebral palsy (CP). No adverse systemic responses were reported. These results support the hypothesis that the transcranial electrical stimulation (TCES) as used in this study is a safe procedure.
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Recent Studies & Clinical Trials
In January 2022, we launched a landmark pilot program with the Seattle Police Department to improve the mental health of 911 dispatchers as well as uniformed police officers. We have also recently completed a clinical trial on using our technology to treat Major Depressive Disorder. The results were so encouraging, we have submitted them to the FDA to obtain approval for the treatment of Major Depressive Disorder in adults.