Effect of TMS on Neuropathic Pain for Patients With Sci

NCT ID: NCT07293780

Last Updated: 2025-12-19

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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active rTMS primer motor cortex

Group Type ACTIVE_COMPARATOR

active TMS

Intervention Type DEVICE

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.

rTMS anterior cingulate gyrus

Group Type EXPERIMENTAL

active TMS

Intervention Type DEVICE

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.

sham rTMS primer motor cortex

Group Type SHAM_COMPARATOR

sham TMS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ayse Naz Kalem

PM&R Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşe Naz Kalem Özgen, specialist

Role: CONTACT

Phone: +90 0312 797 00 00

Email: [email protected]

Facility Contacts

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Ayşe Naz Kalem Özgen

Role: primary

Hatice Ceylan, Specialist

Role: primary

Other Identifiers

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AEŞH-EK-2025-102

Identifier Type: -

Identifier Source: org_study_id