Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34AT008399-01 | U.S. NIH Grant/Contract | View source | |
| 14-1138 | Other Identifier | University of North Carolina - Chapel Hill | |
| Pro00068864 | Other Identifier | Duke University Health System IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Up to half of military veterans with traumatic brain injury (TBI) also suffer from co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic pain, one of the most common health complaints among U.S. veterans who served in Operation Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate that veterans perceive barriers to traditional mental health treatments. Little research exists regarding non-pharmacological, technology-based interventions designed to reduce pain in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI. Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides neurofeedback to induce relaxation). Veterans are taught how to use these together to do neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary data, we hypothesize that participants will show high levels of adherence to the NeuroSky + Mobile Neurofeedback intervention for the 3-month study duration and that participants will show statistically significant reduction in pain symptoms at 3 months compared to baseline. Given links between pain and other outcomes in veterans, we will also explore effects on drug abuse, violence, and suicidality. When the research is complete, the field will be changed because we will know whether new technology reading EEG brainwaves can be used to treat symptoms among individuals suffering from chronic pain. We will also know whether neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to reduce pain and related outcomes. If this program of research is successful, its impact will be to shift approaches to managing pain in clinical practice, for both veterans and civilians
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroSky MindWave Mobile | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ten minute neurofeedback sessions completed on mobile platform | Per protocol, participants will be requested to complete 4 neurofeedback sessions per week for 12 weeks. This data will be collected on participants' mobile devices. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest | Per protocol, participants are enrolled if they have chronic pain defined as self-reporting on the numeric rating scale a score of 4 or above lasting three months or more. The study will therefore ask participants to self report their level of pain (from 0-10, 0 least amount of pain, 10 being the most) following the three months of the neurofeedback sessions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Elbogen, PhD | Duke University, Dept. of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University, Department of Psychiatry | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31697371 | Result | Elbogen EB, Alsobrooks A, Battles S, Molloy K, Dennis PA, Beckham JC, McLean SA, Keith JR, Russoniello C. Mobile Neurofeedback for Pain Management in Veterans with TBI and PTSD. Pain Med. 2021 Feb 23;22(2):329-337. doi: 10.1093/pm/pnz269. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 3 months |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |