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Imaging the Effects of rTMS on Chronic Pain

Primary Purpose

Chronic Pain, Opioid-use Disorder

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active rTMS treatment
Sham rTMS treatment
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Methadone

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Substance Treatment and Research Service (STARS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS stimulation

Sham rTMS stimulation

Arm Description

This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices.

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.

Outcomes

Primary Outcome Measures

Change in pain severity
Measured by the Brief Pain Inventory (BPI)
Change in pain interference
Measured by the Brief Pain Inventory (BPI)
Change in glutamate level in target brain regions
Measured by magnetic resonance spectroscopy (MRS))
Change in gray matter volume in target brain regions
Measured by magnetic resonance imaging (MRI)

Secondary Outcome Measures

Full Information

First Posted
December 23, 2015
Last Updated
November 30, 2022
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02687360
Brief Title
Imaging the Effects of rTMS on Chronic Pain
Official Title
Imaging the Effects of rTMS on Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
funding not received
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid-use Disorder
Keywords
Methadone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS stimulation
Arm Type
Active Comparator
Arm Description
This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices.
Arm Title
Sham rTMS stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active rTMS treatment
Other Intervention Name(s)
rTMS
Intervention Description
In the active treatment, magnetic power output will be delivered to the participants through the coils.
Intervention Type
Device
Intervention Name(s)
Sham rTMS treatment
Intervention Description
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 Measure Information:
Title
Change in pain severity
Description
Measured by the Brief Pain Inventory (BPI)
Time Frame
Baseline versus after 5 weeks of rTMS
Title
Change in pain interference
Description
Measured by the Brief Pain Inventory (BPI)
Time Frame
Baseline versus after 5 weeks of rTMS
Title
Change in glutamate level in target brain regions
Description
Measured by magnetic resonance spectroscopy (MRS))
Time Frame
Baseline versus after 5 weeks of rTMS
Title
Change in gray matter volume in target brain regions
Description
Measured by magnetic resonance imaging (MRI)
Time Frame
Baseline versus after 5 weeks of rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Able to give informed consent, and comply with study procedures. Opioid use disorder, moderate or severe. 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: 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. 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. Cognitive disorder. Currently pregnant. 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. Subjects with positive responses to the Transcranial Magnetic stimulation Adult safety screen (TASS). Currently taking a medication known to increase the risk of seizure. Subjects with claustrophobia making them unable to tolerate MRI scanning. Subjects involved in litigation regarding injury or worker's compensation benefits. Subjects with a diagnosis of vasculitis, peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Martinez, MD
Organizational Affiliation
New York Sate Psychiatric Institute / Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Blevins, MD
Organizational Affiliation
New York State Psychiatric Institute / Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Treatment and Research Service (STARS)
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Imaging the Effects of rTMS on Chronic Pain

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