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Evaluating Neuromodulation Technologies in Early Recovery

NCT ID: NCT01993277

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Depression Anxiety Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fischer Wallace Stimulator

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

Group Type ACTIVE_COMPARATOR

Fischer Wallace Stimulator

Intervention Type DEVICE

Nexalin Brain Stimulator

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

Group Type ACTIVE_COMPARATOR

Nexalin Brain Stimulator

Intervention Type DEVICE

DAVID Delight Stimulator

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

Group Type ACTIVE_COMPARATOR

David Delight Stimulator

Intervention Type DEVICE

Relaxation Therapy

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

Group Type ACTIVE_COMPARATOR

Relaxation Therapy

Intervention Type BEHAVIORAL

Interventions

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Nexalin Brain Stimulator

Intervention Type DEVICE

Fischer Wallace Stimulator

Intervention Type DEVICE

David Delight Stimulator

Intervention Type DEVICE

Relaxation Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Behavioral Health of the Palm Beaches

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tammy Malloy, LCSW

Role: PRINCIPAL_INVESTIGATOR

Behavioral Health of the Palm Beaches

Jodi Star, M.D.

Role: PRINCIPAL_INVESTIGATOR

Behavioral Health of the Palm Beaches

Kate Reynolds, MSW

Role: PRINCIPAL_INVESTIGATOR

Behavioral Health of the Palm Beaches

Locations

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Behavioral Health of the Palm Beaches

North Palm Beach, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Kate Reynolds, MSW

Role: CONTACT

Phone: 561-465-1263

Email: [email protected]

Facility Contacts

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Kate Reynolds

Role: primary

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id