- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411859
Reboot Pain (tDCS)
Reboot Pain: Integrating Neuromodulation Into Clinical Care for Military and Veterans With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study protocol will test whether a non-drug brain stimulation method called Transcranial Direct Current Stimulation (tDCS) can help reduce chronic pain in military service members and veterans who are receiving mental health treatment through the Accelerated Behavioral Health Program (ABHP) at the Emory Healthcare Veterans Program (EHVP). The goal is to see if combining tDCS treatment with standard therapy will improve pain and overall well-being.
The study population will include adult service members and veterans aged 18-89 who are experiencing chronic pain and enrolled in the Accelerated Behavioral Health Program (ABHP) for mental health care. The study will not include minors, prisoners, non-English speakers, or pregnant individuals, as well as those with certain medical contraindications.
Participants will receive short (~20 minute), daily tDCS treatment sessions for two weeks. tDCS is a non-invasive method delivering a weak electrical current to specific areas of the brain to help reduce pain signals. Participants will complete brief daily pain surveys, questionnaires, and standard clinical interviews. The tDCS sessions will either take place in person at Emory's Executive Park Clinic or virtually with assistance as needed.
Participants will receive active tDCS treatment for two weeks and standard of care follow-up assessments at the 3, 6, and 12 month marks after treatment.
Participants will be recruited from those patients already entering or a part of the Emory Healthcare Veterans Program (EHVP) in Atlanta, Georgia.
The total enrollment for this study is up to 100 participants over the course of two years. It is expected that some individuals may not qualify after screening or will withdraw early. No specimens or biological samples will be stored for future research use. Data collected in the study will be de-identified and only used for this protocol.
Participants will review and sign an electronic consent form using a secure online system before active participation in the study. The consent form ensures participants fully understand the study, and they can withdraw at any time without penalty.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Syreese Fuller
- Phone Number: 404-778-3188
- Email: syreese.fuller@emory.edu
Study Contact Backup
- Name: Sheila Rauch, PhD
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30308
- Recruiting
- The Emory Clinic
-
Contact:
- Syreese Fuller
- Phone Number: 404-778-3188
- Email: syreese.fuller@emory.edu
-
Principal Investigator:
- Sheila Rauch, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or Female, 18-89 years old
- Treated on site for ABHP
- Willing to self-administer tDCS and complete the measures
- PEG pain intensity of 4 or more for most of the day at least 3 days per week
- Have an established PCP (Primary Care Provider) or pain management provider
Exclusion Criteria:
- Implanted pacemaker
- Seizure Disorder
- Pregnancy, if applicable
Any new onset of the following:
- Balance Problems
- Difficulty walking
- Bladder incontinence
- Bowel incontinence
- Numbness
- Tingling
- Weakness
Medical contraindications
- Current use of sodium channel blockers
- Lidocaine (OTC/transdermal delivery is ok)
- Mexiletine
- Amitriptyline; other tricyclic antidepressants
Anti-epileptic medications: phenytoin, carbamazepine, lamotrigine, oxcarbazepine, rufinamide, lacosamide and eslicarbazepine acetate
- Current use of calcium channel blockers
- Current use of N-Methyl-D-aspartate receptor antagonists
- Ketamine
- Dextromethorphan
Felbamate
- History of brain surgery
- History of brain tumor
- History of seizure disorder
- History of stroke
- Intracranial metal implantation
- Adults unable to consent
- Individuals who are not yet adults
- Prisoners
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transcranial Direct Current Stimulation (tDCS) plus accelerated Behavioral Health Program
Participants will receive short, daily tDCS treatment sessions for two weeks.
Starting Day 1, tDCS will be administered with a constant current intensity of 2 mA for 20 min per session for up to 10 sessions over 2 weeks.
|
tDCS is a painless brain stimulation treatment that uses direct electrical currents (at a constant, low intensity level) to stimulate specific parts of the brain and help modulate neuronal activity.
Participants will receive a series of tDCS treatments during the Accelerated Brain Health Program (ABHP) coupled with self-report of pain severity and interference tDCS has been used to improve cognitive functions and pain management.
Starting Day 1 of EHVP-IOP, tDCS will be administered with a constant current intensity of 2 mA for 20 min per session for up to 10 sessions over 2 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PEG (Pain, Enjoyment of Life and General Activity) scale
Time Frame: Baseline, day 12 post-intervention (end of treatment)
|
The PEG scale includes 3 questions each rated from 0 (no pain) to 10 (Pain as bad as you can imagine) over the past 24 hours.
Items include average pain, interference in enjoyment, and interference in general activity.
Higher score correlates with worse study outcome.
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Baseline, day 12 post-intervention (end of treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PEG scale
Time Frame: Baseline, 3,6, and 12 months post-intervention
|
The PEG scale includes 3 questions each rated from 0 (no pain) to 10 (Pain as bad as you can imagine) over the past week.
Items include average pain, interference in enjoyment, and interference in general activity.
Higher score correlates with worse study outcome.
|
Baseline, 3,6, and 12 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheila Rauch, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Chronic Pain
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- 2025P012993
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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