Evaluating Neuromodulation Technologies in Early Recovery

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Insomnia; Anxiety
• Intervention / Treatment: Device: Fischer Wallace Stimulator; Device: Nexalin Brain Stimulator; Device: David Delight Stimulator; Behavioral: Relaxation Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • North Palm Beach, Florida, United States, 33408
      • Behavioral Health of the Palm Beaches

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Behavioral Health of the Palm Beaches
• Investigators: Principal Investigator: Tammy Malloy, LCSW, Behavioral Health of the Palm Beaches; Principal Investigator: Jodi Star, M.D., Behavioral Health of the Palm Beaches; Principal Investigator: Kate Reynolds, MSW, Behavioral Health of the Palm Beaches

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: November 16, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 0001 (Researcher)