Transcranial Magnetic Stimulation Therapy in Neuropathic Painful Spinal Cord Injury Patients

NCT05645003 | Recruiting

• 1 other identifier: TMSSKY2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Neuropathic Pain; Neurological Diseases or Conditions

Keywords

Repetitive Transcranial Magnetic Stimulation; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from baseline Visual Analog Scale (VAS) at 15 day and 6 week.

  It is evaluated between 0-10. 10 means severe pain, 0 means no pain. Night and day VAS assessment will be questioned.

  up to 6 week

Secondary Outcomes (5)

• Change from baseline The Leeds Assessment of Neuropathic Symptoms & Signs Pain Scale(LANSS) at 15 day and 6 week.

  up to 6 week

• Change from baseline Short form McGill Pain questionnaire(SF-MPQ) at 15 day and 6 week.

  up to 6 week

• Change from baseline Short form 36 (SF-36) at 15 day and 6 week.

  up to 6 week

• Change from baseline Beck Depression Scale at 15 day and 6 week.

  up to 6 week

• Beck Anxiety Scale at 15 day and 6 week.

  up to 6 week

Study Arms (2)

High-frequency real-time rTMS protocol

EXPERIMENTAL

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.

Device: High-frequency real-time rTMS protocol

Sham rTMS Protocol

SHAM COMPARATOR

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

Device: Sham rTMS Protocol

Interventions

High-frequency real-time rTMS protocol 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.

High-frequency real-time rTMS protocol

Sham rTMS Protocol 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.

Sham rTMS Protocol

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar

Afyonkarahisar, 0300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 27241450 BACKGROUND

• 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.

  PMID: 35663263 BACKGROUND

• 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.

  PMID: 35221889 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

Nuran EYVAZ, MD

CONTACT

+905334262442; n_eyvaz@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: November 15, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

TU (1)