Evaluating Neuromodulation Technologies in Early Recovery

Behavioral Health of the Palm Beaches

Status: Unknown

Conditions: Insomnia; Depression; Anxiety

Treatments: Device: Nexalin Brain Stimulator; Device: Fischer Wallace Stimulator; Device: David Delight Stimulator; Behavioral: Relaxation Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993277

0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Fischer Wallace Stimulator

Active Comparator group

Description:

30 20-minute sessions of the Fischer Wallace Stimulator administered twice-per-day within a 3-week time-frame;

Treatment:

Device: Fischer Wallace Stimulator

Nexalin Brain Stimulator

Active Comparator group

Description:

15 40-minute sessions of Nexalin Brain Stimulator adminsitered once-per-day within a 3-week time-frame

Treatment:

Device: Nexalin Brain Stimulator

DAVID Delight Stimulator

Active Comparator group

Description:

15 40-minute sessions of the DAVID Delight administered once-per-day within a 3-week time-frame

Treatment:

Device: David Delight Stimulator

Relaxation Therapy

Active Comparator group

Description:

15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame

Treatment:

Behavioral: Relaxation Therapy