Repetitive TMS to relieve neuropathic pain after spinal cord injury
The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury
This trial will test whether rTMS aimed at the anterior cingulate cortex reduces chronic neuropathic pain in adults with spinal cord injury compared with motor cortex stimulation or a sham treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 2 sites (Ankara, Yenimahalle and 1 other locations) |
| Trial ID | NCT07293780 on ClinicalTrials.gov |
What this trial studies
Adults with chronic central neuropathic pain after spinal cord injury will receive repetitive transcranial magnetic stimulation (rTMS) targeted to the anterior cingulate cortex, compared with motor cortex stimulation and sham TMS. The intervention arms include active and sham TMS; treatments are delivered in person at participating hospitals. Eligible participants are 18–65 years old, at least 12 months post-injury, with pain below the lesion for at least 6 months and VAS > 4 despite standard pharmacologic and rehabilitative care. Exclusions include epilepsy, metallic or electronic cranial implants, spinal cord stimulator, pacemaker, significant psychiatric illness, and pregnancy; pain due to other causes is also excluded.
Who should consider this trial
Good fit: Adults aged 18–65 who are at least 12 months post–spinal cord injury, have central neuropathic pain below the lesion for ≥6 months with VAS > 4 despite medications and therapy, and meet safety criteria for TMS.
Not a fit: Patients with a history of epilepsy, metallic or electronic cranial implants, spinal cord stimulators, pacemakers, significant psychiatric illness, pregnancy, or pain attributable to other causes (e.g., diabetes, rheumatologic disease) are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the intervention could reduce chronic neuropathic pain and improve daily function and quality of life for people with spinal cord injury.
How similar studies have performed: Previous studies of motor cortex rTMS have shown modest benefits for neuropathic pain, while anterior cingulate targeting is a more novel approach with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients for whom at least 12 months have passed since the date of the event 2. 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 3. Patients aged 18-65 4. Pain not attributable to other causes such as rheumatological diseases or diabetes 5. 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: 1. History of epilepsy 2. Metallic implant in the scalp 3. Cochlear implant 4. Spinal cord stimulator 5. Pacemaker 6. Presence of psychiatric illness 7. Pregnancy
Where this trial is running
Ankara, Yenimahalle and 1 other locations
- Ankara Etlik City Hospital — Ankara, Yenimahalle, Turkey (Türkiye) (Recruiting)
- Gaziler Physical Therapy and Rehabilitation Training and Research Hospital — Ankara, Çankaya, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ayşe Naz Kalem Özgen, specialist
- Email: kalemnaz@gmail.com
- Phone: +90 0312 797 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.