Effect of TMS on Neuropathic Pain for Patients With Sci
The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ayse Naz Kalem Ozgen, Specialist
- Phone Number: +90 0312 797 00 00
- Email: kalemnaz@gmail.com
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06010
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Ayşe Naz Kalem Özgen
- Phone Number: +90 0312 797 00 00
- Email: kalemnaz@gmail.com
-
-
Çankaya
-
Ankara, Çankaya, Turkey (Türkiye), 06800
- Recruiting
- Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
-
Contact:
- Hatice Ceylan, Specialist
- Phone Number: 0312 2911000
- Email: drhaticeceylan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: active rTMS primer motor cortex
|
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.
|
|
Experimental: rTMS anterior cingulate gyrus
|
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 Comparator: sham rTMS primer motor cortex
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time.
The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable".
|
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
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
|
It is a 5-point Likert scale to be used for assessing patient satisfaction.
|
first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neuralgia
- Spinal Cord Injuries
Other Study ID Numbers
Other Study ID Numbers
- AEŞH-EK-2025-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.