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Recruiting NCT07293780

Effect of TMS on Neuropathic Pain for Patients With Sci

No phase Interventional Spinal Cord Injury Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: active TMS, sham TMS.
Who it may be relevant to
Registry conditions: Spinal Cord Injury, Neuropathic Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury

Overview

The aim of this study is to evaluate the efficacy of rTMS targeting the anterior cingulate cortex, another stimulation site that may be effective in the treatment of neuropathic pain, and to compare it with motor cortex stimulation.

Interventions

  • Device active TMS
    Patients in the active or sham primary motor cortex rTMS group will receive active or sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks. Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision.
  • Device sham TMS
    Patients in the active or sham primary motor cortex rTMS group will receive active or sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks. Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision.

Primary outcome measures

  • visual analog scale [Time frame: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]
Secondary outcome measures (3)
  • neuropathic pain scale [Time frame: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]
  • Beck Depression Scale [Time frame: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]
  • 5-point Likert scale [Time frame: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]

Eligibility criteria

Inclusion criteria

  • Patients for whom at least 12 months have passed since the date of the event
  • Patients who meet the International Pain Working Group's criteria for central neuropathic pain below the level of the lesion and who have had pain for at least 6 months
  • Patients aged 18-65
  • Pain not attributable to other causes such as rheumatological diseases or diabetes
  • Patients with VAS > 4 despite maximum dose of pharmacological agents (anticonvulsants, antidepressants, narcotics), exercise and physical therapy agents, taking into account renal function tests and other comorbidities

Exclusion criteria

  • History of epilepsy
  • Metallic implant in the scalp
  • Cochlear implant
  • Spinal cord stimulator
  • Pacemaker
  • Presence of psychiatric illness
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 2 centers
  • Ankara Etlik City Hospital — Ankara
  • Gaziler Physical Therapy and Rehabilitation Training and Research Hospital — Ankara

Identifiers

NCT: NCT07293780 · AEŞH-EK-2025-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗