Pain Management Using Mobile Technology in Veterans With PTSD & TBI

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02237885
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2015
Completion date	November 21, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01659073` - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation	N/A
Recruiting	`NCT05914311` - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration	N/A
Recruiting	`NCT05422456` - The Turkish Version of Functional Disability Inventory
Enrolling by invitation	`NCT05422443` - The Turkish Version of Pain Coping Questionnaire
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04385030` - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury	N/A
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Completed	`NCT05103319` - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed	`NCT03687762` - Back on Track to Healthy Living Study	N/A
Completed	`NCT04171336` - Animal-assisted Therapy for Children and Adolescents With Chronic Pain	N/A
Completed	`NCT03179475` - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury	Phase 4
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Recruiting	`NCT06204627` - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain	N/A
Recruiting	`NCT06060028` - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain	N/A
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Completed	`NCT00983385` - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics	Phase 3
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Terminated	`NCT03538444` - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder	N/A
Not yet recruiting	`NCT05812703` - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pain Management Using Mobile Technology in Veterans With PTSD and TBI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms