Chronic Pain Clinical Trial
Official title:
Imaging the Effects of rTMS on Chronic Pain
NCT number | NCT02687360 |
Other study ID # | 7208 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | October 2025 |
Verified date | January 2024 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic pain is highly prevalent in patients with opioid use disorder on methadone maintenance therapy, and associated with problems related to psychosocial functioning, medical and psychiatric health, and substance craving and use. Neuroimaging has strongly correlated pain processing with the medial prefrontal and dorsal anterior cingulate cortices. This study will investigate the effects of repetitive transcranial magnetic stimulation (rTMS) using the H7 coil targeting these same brain areas for the treatment of chronic pain in patients on methadone maintenance therapy,and magnetic resonance imaging and spectroscopy (MRI/MRS) will be used to evaluate target engagement and mechanism.
Status | Suspended |
Enrollment | 16 |
Est. completion date | October 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Chronic pain (back pain, osteoarthritis, complex regional pain syndrome, phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, or neuropathic facial pain). 2. Able to give informed consent, and comply with study procedures. 3. Opioid use disorder, moderate or severe. 4. Enrolled in methadone maintenance treatment program for at least 2 months and at least 1 month on a stable dose of methadone (up to 300mg/day). Exclusion Criteria: 1. Medical conditions that preclude rTMS, including glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (CVA, TIA) any brain lesions (such multiple sclerosis),or seizure disorders. 2. Meet DSM-5 criteria for major psychiatric illness, such as bipolar disorder, major depression (severe), suicidal thoughts, mania, or psychosis, that would interfere with participation or pose a risk for rTMS. 3. Cognitive disorder. 4. Currently pregnant. 5. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott-Raven press, NY 1998.14. This includes metal or shrapnel or bullet in the head or body, including metal shavings. 6. Subjects with positive responses to the Transcranial Magnetic stimulation Adult safety screen (TASS). 7. Currently taking a medication known to increase the risk of seizure. 8. Subjects with claustrophobia making them unable to tolerate MRI scanning. 9. Subjects involved in litigation regarding injury or worker's compensation benefits. 10. Subjects with a diagnosis of vasculitis, peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia. |
Country | Name | City | State |
---|---|---|---|
United States | Substance Treatment and Research Service (STARS) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain severity | Measured by the Brief Pain Inventory (BPI) | Baseline versus after 5 weeks of rTMS | |
Primary | Change in pain interference | Measured by the Brief Pain Inventory (BPI) | Baseline versus after 5 weeks of rTMS | |
Primary | Change in glutamate level in target brain regions | Measured by magnetic resonance spectroscopy (MRS)) | Baseline versus after 5 weeks of rTMS | |
Primary | Change in gray matter volume in target brain regions | Measured by magnetic resonance imaging (MRI) | Baseline versus after 5 weeks of rTMS |
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