NCT02687360

Imaging the Effects of rTMS on Chronic Pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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 therapy,and magnetic resonance imaging and spectroscopy (MRI/MRS) 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 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.

Conditions

• Chronic Pain
• Opioid-use Disorder

Interventions

Type	Name	Description
DEVICE	Active rTMS treatment	In the active treatment, magnetic power output will be delivered to the participants through the coils.
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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2016-02-22
• Last updated: 2025-04-15
• Results posted: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study