Evaluating Neuromodulation Technologies in Early Recovery

Not Applicable

• Conditions: Depression; Anxiety; Insomnia
• Interventions: Device: Fischer Wallace Stimulator; Device: Nexalin Brain Stimulator; Device: David Delight Stimulator; Behavioral: Relaxation Therapy

• Registration Number: NCT01993277
• Lead Sponsor: Behavioral Health of the Palm Beaches

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-16
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Study Start: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17
• Primary Completion: 2015-06
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fischer Wallace Stimulator	Fischer Wallace Stimulator	30 20-minute sessions of the Fischer Wallace Stimulator administered twice-per-day within a 3-week time-frame;
Nexalin Brain Stimulator	Nexalin Brain Stimulator	15 40-minute sessions of Nexalin Brain Stimulator adminsitered once-per-day within a 3-week time-frame
DAVID Delight Stimulator	David Delight Stimulator	15 40-minute sessions of the DAVID Delight administered once-per-day within a 3-week time-frame
Relaxation Therapy	Relaxation Therapy	15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Brief Substance Craving Scale (BSCS)	Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions

Trial Locations

Locations (1)

Behavioral Health of the Palm Beaches; 🇺🇸 North Palm Beach, Florida, United States