Evaluating Neuromodulation Technologies in Early Recovery

Study Overview
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Brief Summary
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The study is an open-label comparative effectiveness clinical trial evaluating the impact of three neuromodulation treatment devices to improve the mental health and sobriety status of recovering substance abuse patients. We intend to enroll 200 patients to give us a sufficient number of subjects for the planned comparisons. Following informed consent and baseline assessment, patients will be randomly assigned to receive either 1) 15 40-minute sessions of Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device, once-per-day within a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace Stimulator, another CES device, twice-per-day within a 3-week time-frame; 3) 15 40-minute sessions of the DAVID Delight, an audio-visual stimulation device (AVS), once-per-day within a 3-week time-frame; OR 4) the control-group condition of 15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame. All subjects will then be reassessed at the end of the 3 weeks of treatment and again 1, 3, and 6 months later. In addition to the assigned treatments, all patients will also receive the standard array of services that are provided by Behavioral Health of the Palm Beaches (BHOPB) including as clinically appropriate, psychiatric medication management and Eye Movement Desensitization Response (EMDR) therapy. Patients diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed to determine their suitability for EMDR and if suitable, will receive 2 or more EMDR sessions. Patients without PTSD do not receive EMDR therapy.

Official Title
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A Comparator Trial Evaluating Three Neuromodulation Technologies' Effectiveness in Early Recovery From Substance Abuse Disorders as Compared to Relaxation Therapy

Conditions
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Depression, Anxiety, Insomnia

Intervention / Treatment
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* Device: Nexalin Brain Stimulator
* Device: Fischer Wallace Stimulator
* Device: David Delight Stimulator
* Behavioral: Relaxation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder. Exclusion Criteria: The exclusion criteria are patients diagnosed with 1) an uncontrolled seizure disorder, 2) a psychotic disorder with currently active features (e.g., paranoia), 3) a dissociative identity disorder, 4) a manic episode within the past month, 5) patients with a pace-maker or implanted vagal nerve stimulator, patients prescribed Subocone, Subutext, &/or any psychostimulant medication (e.g., Alderol, Concerta, Focalin, Metadate, Vyvance, etc.) since these medications interfere with the ability of these neuromodulation devices' ability to have the intended effect on patients, and 7) pregnant woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fischer Wallace Stimulator<br>30 20-minute sessions of the Fischer Wallace Stimulator administered twice-per-day within a 3-week time-frame; | Device: Fischer Wallace Stimulator<br> <br> |
| Active Comparator: Nexalin Brain Stimulator<br>15 40-minute sessions of Nexalin Brain Stimulator adminsitered once-per-day within a 3-week time-frame | Device: Nexalin Brain Stimulator<br> <br> |
| Active Comparator: DAVID Delight Stimulator<br>15 40-minute sessions of the DAVID Delight administered once-per-day within a 3-week time-frame | Device: David Delight Stimulator<br> <br> |
| Active Comparator: Relaxation Therapy<br>15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame | Behavioral: Relaxation Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quick Inventory of Depressive Symptoms-Self-Report (QIDS-SR) |  | Change in baseline depressive symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup | 
| State-Trait Anxiety Inventory (STAI) |  | Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup | 
| Pittsburgh Sleep Scale (PSS) |  | Change in baseline insomnia symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup | 
| 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) |  | Change in baseline quality of life, after 3 weeks of treatment, and 1, 3, and 6 months followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Substance Craving Scale (BSCS) |  | Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions |