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Evaluating Neuromodulation Technologies in Early Recovery

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ClinicalTrials.gov Identifier: NCT01993277
Recruitment Status : Unknown
Verified December 2014 by Behavioral Health of the Palm Beaches.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2013
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Behavioral Health of the Palm Beaches

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Insomnia Device: Nexalin Brain Stimulator Device: Fischer Wallace Stimulator Device: David Delight Stimulator Behavioral: Relaxation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparator Trial Evaluating Three Neuromodulation Technologies' Effectiveness in Early Recovery From Substance Abuse Disorders as Compared to Relaxation Therapy
Study Start Date : December 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 ]
  2. State-Trait Anxiety Inventory (STAI) [ Time Frame: Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup ]
  3. Pittsburgh Sleep Scale (PSS) [ Time Frame: Change in baseline insomnia symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup ]
  4. 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 ]

Secondary Outcome Measures :
  1. Brief Substance Craving Scale (BSCS) [ Time Frame: Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993277


Contacts
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Contact: Kate Reynolds, MSW 561-465-1263 kreynolds@bhpalmbeach.com

Locations
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United States, Florida
Behavioral Health of the Palm Beaches
North Palm Beach, Florida, United States, 33408
Contact: Kate Reynolds    561-465-1263    kreynolds@bhpalmbeach.com   
Sub-Investigator: Alan Stevens, MSW         
Sponsors and Collaborators
Behavioral Health of the Palm Beaches
Investigators
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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
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Responsible Party: Behavioral Health of the Palm Beaches
ClinicalTrials.gov Identifier: NCT01993277    
Other Study ID Numbers: 0001
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms