Treatment of Neuropathic Pain Following Spinal Cord Injury - a RTMS Approach

December 16, 2024 updated by: University of Calgary

Treatment of Neuropathic Pain Following Spinal Cord Injury - a Repetitive Transcranial Magnetic Stimulation Approach

This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 86,000 Canadians live with a spinal cord injury (SCI). Individuals with a SCI experience varying levels of deficits in motor and sensory function and sometimes paralysis. SCI can result in permanent impairments both physical and psychological, as the loss of body function greatly impacts quality of life. Neuropathic pain (NP) is a common complication following SCI. Damage or dysfunction to the nervous system after SCI commonly leads to secondary injury or disease in the somatosensory system, which may contribute to NP. This debilitating complication can impede many factors including physical function, rehabilitation, sleep, and return to work.

Treatment modalities for NP aim to reduce pain and improve function and quality of life. Pharmacological interventions are considered first-line therapy for NP management, though there remains limited evidence to support the efficacy of this treatment modality. Pharmacologic therapies may also include negative side effects. Additionally, clinical guidelines for NP management recommend including non-pharmacologic strategies. Therefore, an interdisciplinary strategy may be required to effectively mitigate NP after SCI. Evidence of neuromodulation techniques to improve various pain conditions is well established, and reductions in pain may be related to the modified brain activity. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation intervention with a low risk of adverse effects. Preliminary studies investigating rTMS for NP after SCI have shown a therapeutic effect after treatment whereby quality of life and pain improved in this population.

RESEARCH QUESTION AND OBJECTIVES

This study aims to determine the clinical feasibility of a rTMS protocol to improve pain symptomology in adults with NP following SCI. Additionally, this study will contribute to the limited body of evidence for the efficacy of this treatment modality in this population.

The primary objective is to determine symptomatic changes in pain profile and treatment response using the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, a valid and reliably tested instrument, and the PROMIS Scale Neuropathic Pain Quality 5a questionnaire.

Secondary objectives include assessing quality of life (QLI-SCI), depression (PHQ-9), anxiety (GAD-7), disability (WHODAS), and pain catastrophizing (PCS).

METHODS

Clinical Assessments: Demographic information, including age, sex, gender, and past medical history will be collected prior to participation. Participant's neurological level of impairment will be determined by a treating physician, allied health professional, or research study physician. The initial assessment will include answering questionnaires: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, PROMIS Scale Neuropathic Pain Quality 5a questionnaire, Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS), World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Generalized Anxiety Disorder scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and previous medication and treatment questionnaires. Participant's current medication usage will be monitored during the study and rTMS tolerability will be assessed immediately following each treatment session. Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment, at 1 and 3 months after their last rTMS treatment.

TMS Protocol: Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Daily rTMS sessions will include 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with an inter-train interval of 45-seconds. Treatment intensity will be applied at 100-120% of the participant's resting motor threshold (RMT). A RMT is the minimal intensity required to evoke a motor evoked potential and will be obtained by administering single-pulse TMS to the left motor cortex. Electromyography (EMG) electrodes will be placed on the contralateral abductor pollicis brevis (APB) muscle to determine the motor evoked potential peak-to-peak amplitude, requiring 50 microvolts amplitude in 5 of 10 consecutive stimulations. The rTMS treatment will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36). Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physician-diagnosed spinal cord injury
  • Neuropathic pain for at least 3-months, as diagnosed by a physician
  • Pain not attributable to any other conditions
  • Aged 18-75 years
  • Can complete wheelchair transfers independently

Exclusion Criteria:

  • Prior history of transcranial magnetic stimulation (TMS) therapy
  • Any TMS-related contraindications, for example: pacemaker, metallic implant, other medical conditions such as 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 current pregnancy or the desire to become pregnant in the next 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
See experimental arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Neuropathic pain will be assessed using the PROMIS Scale Neuropathic Pain Quality 5a questionnaire. This tool assesses 5 descriptors of neuropathic pain quality. Participants are asked to rate their pain quality from 1(not at all) to 5 (very much) using a recall period of the past 7 days.
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain profile, including location, intensity, and interference over the past 7 days will be assessed using the ISCIPBDS self-report tool.
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Index Spinal Cord Injury version (QLI-SCI)
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Quality of life and satisfaction with aspects of quality of life will be assessed using the QLI-SCI instrument. This questionnaire focuses on the categories of health and functioning, social and economic, psychological/spiritual, and family.
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain Catastrophizing Scale (PCS)
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain experience will be assessed using the PCS. Participants are asked to rate how much they agree with the listed thoughts and feelings they may have when experiencing pain from 0 (not at all) to 4 (all the time).
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
World Health Organization Disability Assessment Schedule (WHODAS) 2.0
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Health and disability will be assessed using the WHODAS 2.0 instrument. Participants will be asked to rate the amount of difficulty that have had completing activities over the past 30 days using the scale none to extreme or cannot do.
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Generalized Anxiety Disorder scale-7 (GAD-7)
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Anxiety will be assessed using the GAD-7 tool. Participants will rate the frequency of anxious feelings from 0 (not at all) to 3 (nearly every day), thinking back over the past 2 weeks. Higher scores will indicate a greater severity of anxiety symptoms.
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Depression will be assessed using the PHQ-9 tool. Participants will rate the frequency of depressive thoughts and/or feelings experienced over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher scores will indicate a greater severity of depressive symptoms.
To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Chantel T Debert, MD MSc FRCPC, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB23-0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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