DepressionNCT01993277
Evaluating Neuromodulation Technologies in Early Recovery
A study testing Nexalin Brain Stimulator, Fischer Wallace Stimulator and David Delight Stimulator in people with Depression and Anxiety, run by Behavioral Health of the Palm Beaches at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Anxiety, Insomnia
- What is being tested?
- Nexalin Brain Stimulator, Fischer Wallace Stimulator and David Delight Stimulator
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health of the Palm Beaches
North Palm Beach, Florida, 33408
Kate Reynolds, 561-465-1263, kreynolds@bhpalmbeach.com
Alan Stevens, MSW
About this study
Official title: 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.
- Conditions
- Depression, Anxiety, Insomnia
- Being tested
- Nexalin Brain Stimulator, Fischer Wallace Stimulator, David Delight Stimulator, Relaxation Therapy
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexalin Brain StimulatorDevice
Fischer Wallace StimulatorDevice
David Delight StimulatorDevice
Relaxation TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Fischer Wallace Stimulator | Active comparator | 30 20-minute sessions of the Fischer Wallace Stimulator administered twice-per-day within a 3-week time-frame; Receives: Device: Fischer Wallace Stimulator |
| Nexalin Brain Stimulator | Active comparator | 15 40-minute sessions of Nexalin Brain Stimulator adminsitered once-per-day within a 3-week time-frame Receives: Device: Nexalin Brain Stimulator |
| DAVID Delight Stimulator | Active comparator | 15 40-minute sessions of the DAVID Delight administered once-per-day within a 3-week time-frame Receives: Device: David Delight Stimulator |
| Relaxation Therapy | Active comparator | 15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame Receives: Behavioral: Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quick Inventory of Depressive Symptoms-Self-Report (QIDS-SR)
Measured: Change in baseline depressive symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
State-Trait Anxiety Inventory (STAI)
Measured: Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup
Pittsburgh Sleep Scale (PSS)
Measured: 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)
Measured: Change in baseline quality of life, after 3 weeks of treatment, and 1, 3, and 6 months followup
Secondary outcomes (1)
Brief Substance Craving Scale (BSCS)
Measured: Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Behavioral Health of the Palm Beaches
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy Malloy, LCSW, Principal investigator, Behavioral Health of the Palm BeachesJodi Star, M.D., Principal investigator, Behavioral Health of the Palm BeachesKate Reynolds, MSW, Principal investigator, Behavioral Health of the Palm Beaches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993277
- Sponsor's protocol ID
- 0001
- Status last verified
- Dec 2014
- First submitted
- 16 Nov 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparator Trial Evaluating Three Neuromodulation Technologies' Effectiveness in Early Recovery From Substance Abuse Disorders as Compared to Relaxation Therapy
- ClinicalTrials.gov ID
- NCT01993277
- Acronym / sponsor ID
- 0001
- Conditions
- Depression, Anxiety, Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Behavioral Health of the Palm BeachesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fischer Wallace Stimulator | Active comparator | Device: Fischer Wallace Stimulator30 20-minute sessions of the Fischer Wallace Stimulator administered twice-per-day within a 3-week time-frame; |
| Nexalin Brain Stimulator | Active comparator | Device: Nexalin Brain Stimulator15 40-minute sessions of Nexalin Brain Stimulator adminsitered once-per-day within a 3-week time-frame |
| DAVID Delight Stimulator | Active comparator | Device: David Delight Stimulator15 40-minute sessions of the DAVID Delight administered once-per-day within a 3-week time-frame |
| Relaxation Therapy | Active comparator | Behavioral: Relaxation Therapy15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexalin Brain Stimulator | Device | Nexalin Brain Stimulator |
| Fischer Wallace Stimulator | Device | Fischer Wallace Stimulator |
| David Delight Stimulator | Device | DAVID Delight Stimulator |
| Relaxation Therapy | Behavioural | Relaxation Therapy |
Primary outcome
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
State-Trait Anxiety Inventory (STAI)
Time frame: 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
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
1 secondary outcome
Brief Substance Craving Scale (BSCS)
Time frame: Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy Malloy, LCSW principal investigator
Behavioral Health of the Palm Beaches
Jodi Star, M.D. principal investigator
Behavioral Health of the Palm Beaches
Kate Reynolds, MSW principal investigator
Behavioral Health of the Palm Beaches
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexalin Brain Stimulator, Fischer Wallace Stimulator and David Delight Stimulator in people with Depression and Anxiety, run by Behavioral Health of the Palm Beaches at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate Reynolds, MSW (561-465-1263, kreynolds@bhpalmbeach.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.