Imaging the Effects of rTMS on Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02687360|
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Opioid-use Disorder||Device: Active rTMS treatment Device: Sham rTMS treatment||Not Applicable|
The research aims of this study are to (1) investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) of the medial prefrontal cortex and dorsal anterior cingulate cortex for the treatment of chronic non-cancer pain in participants with opioid use disorder on methadone-maintenance therapy, and (2) investigate target engagement by measuring changes in gray matter volume and glutamate-glutamine in these brain regions by magnetic resonance imaging and spectroscopy. Given the high incidence of chronic pain in the OUD population and specifically the methadone-maintained population, there is great need for effective treatments. Untreated chronic pain contributes to medical and psychiatric problems, reduced quality of life, and increased risk of substance use and overdose. Non-invasive neuromodulation like rTMS, which is currently FDA-approved for treatment-resistant depression and OCD, holds promise as a safe and effective therapeutic. This project will investigate rTMS of brain regions known to process the affective and cognitive components of chronic pain, utilizing a treatment protocol modeled after the FDA-approved protocol for obsessive-compulsive disorder.
Volunteers will be randomized in a double-blind manner to 25 sessions (5 weeks) of either active high-frequency rTMS or sham stimulation. Participants will regularly complete measures to evaluate changes in pain severity and interference. The primary clinical outcome measures will be pain severity and interference scores on the Brief Pain Inventory (BPI). Additionally, participants will undergo MRI/MRS scans before and after the 5 weeks of rTMS to evaluate target engagement and help elucidate the potential mechanism of action of the intervention.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Imaging the Effects of rTMS on Chronic Pain|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||October 2021|
Active Comparator: Active rTMS stimulation
This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices.
Device: Active rTMS treatment
In the active treatment, magnetic power output will be delivered to the participants through the coils.
Other Name: rTMS
Sham Comparator: Sham rTMS stimulation
The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself.
Device: Sham rTMS treatment
The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
- Change in pain severity [ Time Frame: Baseline versus after 5 weeks of rTMS ]Measured by the Brief Pain Inventory (BPI)
- Change in pain interference [ Time Frame: Baseline versus after 5 weeks of rTMS ]Measured by the Brief Pain Inventory (BPI)
- Change in glutamate level in target brain regions [ Time Frame: Baseline versus after 5 weeks of rTMS ]Measured by magnetic resonance spectroscopy (MRS))
- Change in gray matter volume in target brain regions [ Time Frame: Baseline versus after 5 weeks of rTMS ]Measured by magnetic resonance imaging (MRI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687360
|Contact: Derek Blevins, MDemail@example.com|
|Contact: Diana Martinez, MDfirstname.lastname@example.org|
|United States, New York|
|Substance Treatment and Research Service (STARS)||Recruiting|
|New York, New York, United States, 10019|
|Contact: Diana Martinez, MD 646-774-6160|
|Principal Investigator: Derek Blevins, MD|
|Principal Investigator:||Diana Martinez, MD||New York Sate Psychiatric Institute / Columbia University|
|Principal Investigator:||Derek Blevins, MD||New York State Psychiatric Institute / Columbia University|