Transcranial Magnetic Stimulation Therapy in Neuropathic Painful Spinal Cord Injury Patients

NCT ID: NCT05645003

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2026-03-31

Brief Summary

The aim of our study is to investigate the effect of high-frequency Repetitive Transcranial Magnetic Stimulation(rTMS) therapy applied to the dorsolateral PFC (DLPFC) area on neuropathic pain in patients with spinal cord injury. In this area, there are very few studies on the effectiveness of rTMS treatment added to medical treatment in neuropathic pain. In addition, the number of studies comparing the effect of rTMS therapy applied to the DLFPC area is very few.

Detailed Description

Spinal cord injury (SCI) is associated with widespread disability due to its detrimental effects on various bodily functions. Neuropathic pain is one of the most challenging complications after SCI and can have a significant impact on daily life.

There are supportive criteria for the diagnosis of neuropathic pain associated with SCI: onset of pain within one year after SCI, absence of primary association between pain with movement, inflammation or other local tissue damage, burning, tingling, pins and needles, throbbing pain, squeezing pain, Detection of 1 or more of the pain descriptors such as freezing pain, allodynia or hyperalgesia within the pain distribution support neuropathic pain due to spinal cord injury.

Pharmacological and interventional treatments are often tried in the treatment of neuropathic pain, but their success is often limited. Another option that has been used as an innovative approach in the treatment of neuropathic pain in recent years is pain regulation with rTMS. As one of the non-invasive brain stimulation techniques, rTMS is suggested to be useful in the treatment of central neuropathic pain. While most studies to date have mainly targeted the primary motor cortex (M1), which is contralateral to the pain side, fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral PFC (DLPFC). The analgesic mechanisms of rTMS to the DLPFC are thought to be through the same mechanism as stimulation of the M1 motor cortex.

The aim of our study; To investigate the effect of high frequency rTMS applications on patients with SCI on their neuropathic pain.

Conditions

Spinal Cord Injuries; Neuropathic Pain; Neurological Diseases or Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High-frequency real-time rTMS protocol

It was planned to apply a total of 1200 beats to the dorsolateral prefrontal cortex daily at a frequency of 10 HZ at 110% intensity of the motor threshold for 15 sessions.

Group Type: EXPERIMENTAL

High-frequency real-time rTMS protocol

Intervention Type: DEVICE

It was planned to apply a total of 1200 beats to the dorsolateral prefrontal cortex daily for 15 sessions. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment (pregabalin, gabapentin, carbamazepine) at the same effective dose. No dose changes will be made during rTMS sessions.

Sham rTMS Protocol

It was planned to apply daily sham rTMS to the dorsolateral prefrontal cortex for 15 sessions.

Group Type: SHAM_COMPARATOR

Sham rTMS Protocol

Intervention Type: DEVICE

It was planned to apply a to the dorsolateral prefrontal cortex daily for 15 sessions. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment (pregabalin, gabapentin, carbamazepine) at the same effective dose. No dose changes will be made during rTMS sessions.

Interventions

High-frequency real-time rTMS protocol

It was planned to apply a total of 1200 beats to the dorsolateral prefrontal cortex daily for 15 sessions. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment (pregabalin, gabapentin, carbamazepine) at the same effective dose. No dose changes will be made during rTMS sessions.

Intervention Type: DEVICE

Sham rTMS Protocol

It was planned to apply a to the dorsolateral prefrontal cortex daily for 15 sessions. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment (pregabalin, gabapentin, carbamazepine) at the same effective dose. No dose changes will be made during rTMS sessions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Between the ages of 20-70, who applied to the AFSU Physical Medicine and Rehabilitation inpatient service with the diagnosis of spinal cord injury and

• Having spinal cord injury with neurophatic pain at least six months ago,
• Able to follow two-stage verbal commands,
• Agreeing to participate in the study voluntarily and regularly,
• Patients who are medically stable (no previous myocardial infarction, no musculoskeletal problems) will be included in our study.

Exclusion Criteria

Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,

• Epilepsy,
• History of antiepileptic drug use,
• Intracranial metal object,
• Presence of in-ear implant,
• Cognitive dysfunction,
• Lower extremity peripheral nerve injury,
• With malignancy and active infection,
• Infection on the skin in the application area,
• Having an open wound,
• Having inflammatory disease,
• Orthopedic injuries that can limit maximum effort contractions,
• Having a brain lesion or a history of drug use that will affect the seizure threshold,
• Patients with increased intracranial pressure or uncontrolled migraine will not be included.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Nuran Eyvaz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuran EYVAZ, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Afyonkarahisar

Afyonkarahisar, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nuran EYVAZ, MD

Role: CONTACT

n_eyvaz@hotmail.com

+905334262442

Facility Contacts

Nuran EYVAZ, MD

Role: primary

n_eyvaz@hotmail.com

05334262442

References

Nardone R, Holler Y, Langthaler PB, Lochner P, Golaszewski S, Schwenker K, Brigo F, Trinka E. rTMS of the prefrontal cortex has analgesic effects on neuropathic pain in subjects with spinal cord injury. Spinal Cord. 2017 Jan;55(1):20-25. doi: 10.1038/sc.2016.87. Epub 2016 May 31.

Reference Type: BACKGROUND

PMID: 27241450 (View on PubMed)

Yang QH, Zhang YH, Du SH, Wang YC, Fang Y, Wang XQ. Non-invasive Brain Stimulation for Central Neuropathic Pain. Front Mol Neurosci. 2022 May 19;15:879909. doi: 10.3389/fnmol.2022.879909. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35663263 (View on PubMed)

Li L, Huang H, Yu Y, Jia Y, Liu Z, Shi X, Wang F, Zhang T. Non-invasive Brain Stimulation for Neuropathic Pain After Spinal Cord Injury: A Systematic Review and Network Meta-Analysis. Front Neurosci. 2022 Feb 11;15:800560. doi: 10.3389/fnins.2021.800560. eCollection 2021.

Reference Type: BACKGROUND

PMID: 35221889 (View on PubMed)

Other Identifiers

TMSSKY2022

Identifier Type: -

Identifier Source: org_study_id