Chronic PainNCT02687360

Imaging the Effects of rTMS on Chronic Pain

A study testing Active rTMS treatment in people with Chronic Pain and Opioid-use Disorder, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 60 years
Conditions the study is for: Chronic Pain, Opioid-use Disorder
What is being tested?: Active rTMS treatment
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2019to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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).

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Substance Treatment and Research Service (STARS)
New York, New York, 10019

Other trials in United States

About this study

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.

Read the 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
Being tested: Active rTMS treatment, Sham rTMS treatment
Keywords: Methadone
Medical subject headings: Chronic Pain, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active rTMS treatmentDevice
Also called rTMS
In the active treatment, magnetic power output will be delivered to the participants through the coils.
Sham rTMS treatmentDevice
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.

Study groups in NCT02687360
Study group	Role	What they receive
Active rTMS stimulation	Active comparator	This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Receives: Device: Active rTMS treatment
Sham rTMS stimulation	Sham comparator	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. Receives: Device: Sham rTMS treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: Ability to Recruit and to Have Participants Complete the Study
Number of participants with chronic pain and comorbid psychiatric disorders who complete 60% of sessions.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201931 Aug 2022

First posted22 Feb 2016 (estimated)
Study start1 Sep 2019
Primary completion31 Aug 2022
Study completion31 Aug 2022

Why it stopped: funding not received

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02687360
Sponsor's protocol ID: 7208
Status last verified: Mar 2025
First submitted: 23 Dec 2015
Last updated: 15 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Imaging the Effects of rTMS on Chronic Pain
ClinicalTrials.gov ID: NCT02687360
Acronym / sponsor ID: 7208
Conditions: Chronic Pain, Opioid-use Disorder
Keywords: Methadone
Study type: Interventional
Recruitment status: TerminatedReason stopped: funding not received
Enrolment: 7 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: 1 Sep 2019 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 22 Feb 2016 (estimated)
Results: Posted 15 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active rTMS stimulation	Active comparator	Device: Active rTMS treatmentThis arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices.
Sham rTMS stimulation	Sham comparator	Device: Sham rTMS treatmentThe 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.

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active rTMS treatmentAlso: rTMSIn the active treatment, magnetic power output will be delivered to the participants through the coils.	Device	Active rTMS stimulation
Sham rTMS treatmentThe 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.	Device	Sham rTMS stimulation

Primary outcome

Feasibility: Ability to Recruit and to Have Participants Complete the Study
Time frame: 3 months
Number of participants with chronic pain and comorbid psychiatric disorders who complete 60% of sessions.

Results and safety

Results posted to the registry on 15 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active rTMS Stimulation	4	1
Sham rTMS Stimulation	3	3

Primary outcome: Feasibility: Ability to Recruit and to Have Participants Complete the Study

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Active rTMS Stimulation n = 4	Sham rTMS Stimulation n = 3
Value	4	3

Population analysed: In this feasibility study all participants were included in determining feasibility.

Adverse events

Time frame: Participants were followed for 9 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active rTMS Stimulation	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Sham rTMS Stimulation	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diana Martinez, MD principal investigator

New York Sate Psychiatric Institute / Columbia University

Derek Blevins, MD principal investigator

New York State Psychiatric Institute / Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS treatment in people with Chronic Pain and Opioid-use Disorder, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Ability to Recruit and to Have Participants Complete the Study (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02687360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.