Evaluating Neuromodulation Technologies in Early Recovery

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01993277
• Other study ID #: 0001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2013
• Last updated: December 16, 2014
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Behavioral Health of the Palm Beaches
• Contact: Kate Reynolds, MSW
• Phone: 561-465-1263
• Email: kreynolds[@]bhpalmbeach.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Insomnia

Intervention

Device:
• Nexalin Brain Stimulator

• Fischer Wallace Stimulator

• David Delight Stimulator

Behavioral:
• Relaxation Therapy

Locations

Country	Name	City	State
United States	Behavioral Health of the Palm Beaches	North Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Behavioral Health of the Palm Beaches

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	State-Trait Anxiety Inventory (STAI)		Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup	No
Primary	Pittsburgh Sleep Scale (PSS)		Change in baseline insomnia symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup	No
Primary	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	No
Secondary	Brief Substance Craving Scale (BSCS)		Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions	No