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Neuromodulatory Treatments for Pain Management in Complex TBI - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about improving the quality of treatments for veterans with TBI and pain, using non-pharmacological (non-medication) treatments called 'neuromodulatory' treatments.   These treatments are intended to reduce pain by helping you learn how to increase physical and psychological relaxation.  
What is the Condition Being Studied?
Chronic pain in Veterans

Who Can Participate in the Study?

Adults who:
- Served in a branch of the US military since October 2001  
- Have experienced a head injury  
- Currently experience chronic pain

Age Group

What is Involved?

If you choose to join this study, you will:

- Have 3 visits at Duke, lasting 3-4 hours each, over a period of 6 months.  
- Be given an iPod touch and randomized (like drawing numbers from a hat) to use 1 of 3 different study apps.
- Be asked to use the app 10 minutes at a time at least 4 times per week for 3 months.  
- Receive two phone calls and two visits at your home or somewhere else convenient to support your use of the study app.  
- Be asked to fill out questionnaires about your history and your health.  
- Be asked to do a saliva drug test 3 times throughout the study.  
- Be asked to have an EEG and ECG 3 times throughout the study.

Study Details

Full Title
Neuromodulatory Treatments for Pain Management in Complex TBI Using Mobile Technology
Principal Investigator
Protocol Number
IRB: PRO00088360
NCT: NCT03418129
Contact the Duke Recruitment Innovation Center