High-frequency real-time rTMS DLPF cortex protocol: It was planned to apply the dorsolateral prefrontal cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
High-frequency real-time rTMS M1 motor cortex protocol: It was planned to apply the M1 motor cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
Sham rTMS Protocol: It was planned to apply the daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
Study summary
The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Aged 18-75 years Physician-diagnosed spinal cord injury for at least 3-months Neuropathic pain for at least 3-months Pain not attributable to any other conditions
Exclusion Criteria:
* Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, uncontrolled hypertension,arrhythmia, pacemaker)
* Neurodegenerative disease
* Epilepsy
* History of antiepileptic drug use
* Cognitive dysfunction
* Lower extremity peripheral nerve injury
* Increased intracranial pressure or uncontrolled migraine
* Infection on the skin in the application area.
* Having a brain lesion or a history of drug use that will affect the seizure threshold.
Any TMS-related contraindications, for example:
* Pacemaker
* Metallic implant
* Previous seizure
* Psychiatric disorders (excluding depression and anxiety)
* Malignancy
* Current pregnancy
Primary outcome measure(s)
Change from baseline Brief Pain Inventory-Short Form (BPI-SF) at 1. and 2 months. — To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment. The Brief Pain Inventory Short Form (SPI-SF) is designed to examine pain in terms of sensory (pain intensity) and impact on daily functioning. The BPI-SF consists of two parts. The first part assesses the severity of worst, mildest, average and momentary pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates "no pain at all" and a response of 10 indicates "the most severe pain imaginable". The second part consists of seven questions assessing how much pain affects daily functioning, including general activity and enjoyment of life. A response of 0 indicates "not at all affected" and a response of 10 indicates "completely affected". The total score ranges from 0-70. Higher scores indicate worsening symptoms.
Trial sites (1)
Facility
City
Region
Status
Afyonkarahisar Health Sciences University
Afyonkarahisar
Turkey (Türkiye)
Recruiting
More Afyonkarahisar Health Sciences University trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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