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

NCT06284694 | Active Not Recruiting

• 1 other identifier: REB23-0120
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Neuropathic Pain

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

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

  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.

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

  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.

Secondary Outcomes (5)

• Quality of Life Index Spinal Cord Injury version (QLI-SCI)

  To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.

• Pain Catastrophizing Scale (PCS)

  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

  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)

  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)

  To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.

Study Arms (1)

Repetitive Transcranial Magnetic Stimulation (rTMS)

EXPERIMENTAL

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)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

See experimental arm description

Repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (9)

• Burke D, Fullen BM, Stokes D, Lennon O. Neuropathic pain prevalence following spinal cord injury: A systematic review and meta-analysis. Eur J Pain. 2017 Jan;21(1):29-44. doi: 10.1002/ejp.905. Epub 2016 Jun 24.

  PMID: 27341614 BACKGROUND

• Hatch MN, Cushing TR, Carlson GD, Chang EY. Neuropathic pain and SCI: Identification and treatment strategies in the 21st century. J Neurol Sci. 2018 Jan 15;384:75-83. doi: 10.1016/j.jns.2017.11.018. Epub 2017 Nov 16.

  PMID: 29249383 BACKGROUND

• Almeida C, Monteiro-Soares M, Fernandes A. Should Non-Pharmacological and Non-Surgical Interventions be Used to Manage Neuropathic Pain in Adults With Spinal Cord Injury? - A Systematic Review. J Pain. 2022 Sep;23(9):1510-1529. doi: 10.1016/j.jpain.2022.03.239. Epub 2022 Apr 10.

  PMID: 35417793 BACKGROUND

• Shen Z, Li Z, Ke J, He C, Liu Z, Zhang D, Zhang Z, Li A, Yang S, Li X, Li R, Zhao K, Ruan Q, Du H, Guo L, Yin F. Effect of non-invasive brain stimulation on neuropathic pain following spinal cord injury: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Aug 21;99(34):e21507. doi: 10.1097/MD.0000000000021507.

  PMID: 32846761 BACKGROUND

• Saleh C, Ilia TS, Jaszczuk P, Hund-Georgiadis M, Walter A. Is transcranial magnetic stimulation as treatment for neuropathic pain in patients with spinal cord injury efficient? A systematic review. Neurol Sci. 2022 May;43(5):3007-3018. doi: 10.1007/s10072-022-05978-0. Epub 2022 Mar 3.

  PMID: 35239053 BACKGROUND

• Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.

  PMID: 18003941 BACKGROUND

• Sun X, Long H, Zhao C, Duan Q, Zhu H, Chen C, Sun W, Ju F, Sun X, Zhao Y, Xue B, Tian F, Mou X, Yuan H. Analgesia-enhancing effects of repetitive transcranial magnetic stimulation on neuropathic pain after spinal cord injury:An fNIRS study. Restor Neurol Neurosci. 2019;37(5):497-507. doi: 10.3233/RNN-190934.

  PMID: 31381538 BACKGROUND

• Seminowicz DA, Moayedi M. The Dorsolateral Prefrontal Cortex in Acute and Chronic Pain. J Pain. 2017 Sep;18(9):1027-1035. doi: 10.1016/j.jpain.2017.03.008. Epub 2017 Apr 8.

  PMID: 28400293 BACKGROUND

• Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008.

  PMID: 15546593 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Chantel T Debert, MD MSc FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive active rTMS treatment.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 29, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)