Chronic Pain
Conditions
Brief summary
This study will examine the effectiveness of tDCS (Transcranial Direct Current Stimulation) in reducing chronic pain when used with Emory Healthcare Veterans Program (EHVP)-ABHP (Accelerated Behavioral Health Program) participants as measured by the Pain, Enjoyment of Life and General Activity Scale (PEG).
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.
Interventions
DEVICETranscranial Direct Current Stimulation
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
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PEG (Pain, Enjoyment of Life and General Activity) scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PEG scale | 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. |
Countries
United States
Contacts
CONTACTSyreese Fuller
CONTACTSheila Rauch, PhD
PRINCIPAL_INVESTIGATORSheila Rauch, PhD
Emory University
Outcome results
None listed