Evaluating Neuromodulation Technologies in Early Recovery

December 16, 2014 updated by: Behavioral Health of the Palm Beaches

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • North Palm Beach, Florida, United States, 33408
        • Behavioral Health of the Palm Beaches
        • Contact:
        • Sub-Investigator:
          • Alan Stevens, MSW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Change in baseline depressive symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
Change in baseline depressive symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
State-Trait Anxiety Inventory (STAI)
Time Frame: Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
Pittsburgh Sleep Scale (PSS)
Time Frame: Change in baseline insomnia symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
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)
Time Frame: Change in baseline quality of life, after 3 weeks of treatment, and 1, 3, and 6 months followup
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)
Time Frame: Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions
Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 0001 (Cancer Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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