Clinical trial NCT06726954: Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation Therapy in Neuropathic Pain Associated With Spinal Cord Injury; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Keywords: Transcranial Magnetic Stimulation
Spinal Cord Injury
Neuropathic Pain
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Spinal cord injury is a disability that causes the loss of many functions for example motor,sensory and autonomic functions in the body. Neuropathic pain is a common problem in participants with spinal cord injury. Many treatment options have been offered for a debilitating condition that has major negative effects on participant's quality of life but provides limited effects and many secondary effects. There is evidence for neuromodulation techniques to improve many pain conditions, such as neuropathic pain. One innovative method for neuropathic pain management, rTMS, is a non-invasive neuromodulation intervention with a low risk of side effects that works by altering brain activity. While most studies to date have mainly targeted the primary motor cortex (M1), fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral prefrontal cortex (DLPFC).

The initial assessment will include answering questionnaires: Brief Pain Inventory, Neuropathic Pain Symptom Inventory(NPSI), International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, Patient Catastrophizing Scale(PCS), Beck Depression Inventory,Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS),Pittsburgh Sleep Quality Index and previous medication and treatment questionnaires.Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment and at 2 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 at a frequency of 10 Hz, treatment intensity will be applied at 120% of the participants 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 participant a will be seated in a comfortable chair or their wheelchair for each rTMS session.

Participants with spinal cord injury receiving rTMS in DLPFC or M1 protocol in addition to neurological rehabilitation will be compared with the sham rTMS group in terms of neuropathic pain, sleep quality, depression and quality of life.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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
* Current pregnancy

Primary outcomes:
measure: Change from baseline Brief Pain Inventory-Short Form (BPI-SF) at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Secondary outcomes:
measure: Change from baseline International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change from baseline Quality of Life Index Spinal Cord Injury version (QLI-SCI) at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change from baseline Pain Catastrophizing Scale (PCS) at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change from baseline Beck Depression Inventory (BDI) Scores at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change in the Patient's Global Impression of Change (PGIC) observed at 1 month and 2 months.
timeFrame: To be assessed after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change from baseline Neuropathic Pain Symptom Inventory (NPSI) at 1.and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
measure: Change from baseline Modified Ashworth Scale (MAS) at 1. and 2 months.
timeFrame: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran Eyvaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.