Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02687360
Status:
SUSPENDED
Last Update Posted:
2024-01-25
First Post:
2015-12-23
Brief Title:
Imaging the Effects of rTMS on Chronic Pain
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Imaging the Effects of rTMS on Chronic Pain
Status:
SUSPENDED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding not received
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 therapyand magnetic resonance imaging and spectroscopy MRIMRS will be used to evaluate target engagement and mechanism
Detailed Description:
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 MRIMRS scans before and after the 5 weeks of rTMS to evaluate target engagement and help elucidate the potential mechanism of action of the intervention
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 MRIMRS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None