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Imaging the Effects of rTMS on Chronic Pain

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ClinicalTrials.gov Identifier: NCT02687360
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Diana Martinez, New York State Psychiatric Institute

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 therapy,and magnetic resonance imaging and spectroscopy (MRI/MRS) will be used to evaluate target engagement and mechanism.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid-use Disorder Device: Active rTMS treatment Device: Sham rTMS treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in pain severity [ Time Frame: Baseline versus after 5 weeks of rTMS ]
    Measured by the Brief Pain Inventory (BPI)

  2. Change in pain interference [ Time Frame: Baseline versus after 5 weeks of rTMS ]
    Measured by the Brief Pain Inventory (BPI)

  3. Change in glutamate level in target brain regions [ Time Frame: Baseline versus after 5 weeks of rTMS ]
    Measured by magnetic resonance spectroscopy (MRS))

  4. Change in gray matter volume in target brain regions [ Time Frame: Baseline versus after 5 weeks of rTMS ]
    Measured by magnetic resonance imaging (MRI)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Derek Blevins, MD 646-774-6133 derek.blevins@nyspi.columbia.edu
Contact: Diana Martinez, MD 646-774-6160 dm437@cumc.columbia.edu

Locations
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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         
Sponsors and Collaborators
New York State Psychiatric Institute
Alkermes, Inc.
Investigators
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Principal Investigator: Diana Martinez, MD New York Sate Psychiatric Institute / Columbia University
Principal Investigator: Derek Blevins, MD New York State Psychiatric Institute / Columbia University
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Responsible Party: Diana Martinez, Professor of Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02687360    
Other Study ID Numbers: 7208
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Diana Martinez, New York State Psychiatric Institute:
Methadone
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms