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

NCT ID: NCT06726954

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2026-09-15

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries Neuropathic Pain

Keywords

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Transcranial Magnetic Stimulation Spinal Cord Injury Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple

Study Groups

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First Group

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.

Group Type EXPERIMENTAL

High-frequency real-time rTMS DLPF cortex protocol

Intervention Type 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.

Second Group

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.

Group Type EXPERIMENTAL

High-frequency real-time rTMS M1 motor cortex protocol

Intervention Type 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.

Third Group

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

Group Type SHAM_COMPARATOR

Sham rTMS Protocol

Intervention Type 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.

Interventions

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High-frequency real-time rTMS DLPF cortex protocol

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.

Intervention Type DEVICE

High-frequency real-time rTMS M1 motor cortex protocol

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.

Intervention Type DEVICE

Sham rTMS Protocol

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Nuran Eyvaz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuran Eyvaz, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

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Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayse Kalender, MD

Role: CONTACT

Phone: +905389563559

Email: [email protected]

Nuran Eyvaz, MD

Role: CONTACT

Phone: +905334262442

Email: [email protected]

Facility Contacts

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Ayşe Kalender, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 34196698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31901449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35239053 (View on PubMed)

Other Identifiers

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TMSSCINP

Identifier Type: -

Identifier Source: org_study_id