Reboot Pain: Integrating Neuromodulation Into Clinical Care for Military and Veterans With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in PEG (Pain, Enjoyment of Life and General Activity) scale
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Implanted pacemaker
- •Seizure Disorder
- •Pregnancy, if applicable
- •Any new onset of the following:
- •Balance Problems
- •Difficulty walking
- •Bladder incontinence
- •Bowel incontinence
- •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
- •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
研究组 & 干预措施
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.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change in PEG (Pain, Enjoyment of Life and General Activity) scale
时间窗: 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.
次要结局
- Change in PEG scale(Baseline, 3,6, and 12 months post-intervention)