Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain

NCT06726954 | Recruiting

• 1 other identifier: TMSSCINP
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Keywords

Transcranial Magnetic Stimulation; Spinal Cord Injury; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline Brief Pain Inventory-Short Form (BPI-SF) at 1. and 2 months.

  The Brief Pain Inventory Short Form (SPI-SF) is designed to examine pain in terms of sensory (pain intensity) and impact on daily functioning. The BPI-SF consists of two parts. The first part assesses the severity of worst, mildest, average and momentary pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates "no pain at all" and a response of 10 indicates "the most severe pain imaginable". The second part consists of seven questions assessing how much pain affects daily functioning, including general activity and enjoyment of life. A response of 0 indicates "not at all affected" and a response of 10 indicates "completely affected". The total score ranges from 0-70. Higher scores indicate worsening symptoms.

  To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.

Secondary Outcomes (8)

• Change from baseline International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version at 1. and 2 months.

  To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.

• Change from baseline Quality of Life Index Spinal Cord Injury version (QLI-SCI) at 1. and 2 months.

  To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.

• Change from baseline Pain Catastrophizing Scale (PCS) at 1. and 2 months.

  To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.

• Change from baseline Beck Depression Inventory (BDI) Scores at 1. and 2 months.

  To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.

• Change in the Patient's Global Impression of Change (PGIC) observed at 1 month and 2 months.

  To be assessed after rTMS treatment (1-month) and 2-months after rTMS treatment.

Study Arms (3)

First Group

EXPERIMENTAL

High-frequency real-time rTMS protocol It was planned to apply the dorsolateral prefrontal cortex daily at a frequency of 10 Hz for 20 sessions.

Device: High-frequency real-time rTMS DLPF cortex protocol

Second Group

EXPERIMENTAL

High-frequency real-time rTMS protocol It was planned to apply the M1 motor cortex daily at a frequency of 10 Hz for 20 sessions.

Device: High-frequency real-time rTMS M1 motor cortex protocol

Third Group

SHAM COMPARATOR

Sham rTMS Protocol It was planned to apply daily sham rTMS for 20 sessions.

Device: Sham rTMS Protocol

Interventions

High-frequency real-time rTMS DLPF cortex protocol DEVICE

It was planned to apply the dorsolateral prefrontal cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.

First Group

High-frequency real-time rTMS M1 motor cortex protocol DEVICE

It was planned to apply the M1 motor cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.

Second Group

Sham rTMS Protocol DEVICE

It was planned to apply the daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.

Third Group

Eligibility Criteria

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

You may qualify if:

• Aged 18-75 years Physician-diagnosed spinal cord injury for at least 3-months Neuropathic pain for at least 3-months Pain not attributable to any other conditions

You may not qualify if:

• Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, uncontrolled hypertension,arrhythmia, pacemaker)
• Neurodegenerative disease
• Epilepsy
• History of antiepileptic drug use
• Cognitive dysfunction
• Lower extremity peripheral nerve injury
• Increased intracranial pressure or uncontrolled migraine
• Infection on the skin in the application area.
• Having a brain lesion or a history of drug use that will affect the seizure threshold.
• Any TMS-related contraindications, for example:
• Pacemaker
• Metallic implant
• Previous seizure
• Psychiatric disorders (excluding depression and anxiety)
• Malignancy

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 0300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208.

  PMID: 34196698 BACKGROUND

• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

  PMID: 31901449 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

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Nuran Eyvaz, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Kalender, MD

CONTACT

+905389563559; aysebuber007@gmail.com

Nuran Eyvaz, MD

CONTACT

+905334262442; eyvaznuran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

TU (1)