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Behavioural Intervention

rTMS for Neuropathic Pain After Spinal Cord Injury

N/A

Recruiting

Led By Chantel T Debert, MD MSc FRCPC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neuropathic pain for at least 3 months, as diagnosed by a physician

Physician-diagnosed spinal cord injury

Must not have

Prior history of transcranial magnetic stimulation (TMS) therapy

Presence of any TMS-related contraindications such as pacemaker, metallic implant, structural brain disease, previous seizure, psychiatric disorders (excluding depression and anxiety), suicide attempt in the past 6 months, liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and pregnancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment.

Awards & highlights

No Placebo-Only Group

Summary

"This trial will investigate whether a type of brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can help reduce pain in adults with neuropathic pain after a spinal cord injury."

Who is the study for?

This trial is for adults aged 18-75 with neuropathic pain lasting at least 3 months due to a spinal cord injury. Candidates must not have other conditions causing the pain, no prior TMS therapy, and no contraindications like pacemakers, metal implants in the head, seizures, severe psychiatric disorders, or uncontrolled major diseases.

What is being tested?

The study tests whether repetitive Transcranial Magnetic Stimulation (rTMS) can relieve neuropathic pain in individuals who've suffered a spinal cord injury. rTMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.

What are the potential side effects?

Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. Rarely it may cause seizures or hearing loss if ear protection isn't used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with nerve pain for at least 3 months.

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I have a spinal cord injury diagnosed by a doctor.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously undergone TMS therapy.

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I do not have a pacemaker, metal implants, serious brain issues, seizures, severe mental health issues, recent suicide attempts, liver or kidney disease, cancer, uncontrolled high blood pressure or diabetes, and I am not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed at baseline, after rtms treatment (1-month), and at 1-month and 3-months after rtms treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version

Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a

Secondary study objectives

Generalized Anxiety Disorder scale-7 (GAD-7)

Pain Catastrophizing Scale (PCS)

Patient Health Questionnaire-9 (PHQ-9)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment1 Intervention

Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Treatment intensity will be applied at 100-120% of the participant's resting motor threshold. The neurostimulation protocol will be 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with inter-train interval of 45-seconds. The rTMS will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36) on a standardized brain. Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation (rTMS)

2019

Completed Phase 2

~780

0 / 5Eligibility criteria met