Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain

Afyonkarahisar Health Sciences University

Status: Enrolling

Conditions: Spinal Cord Injuries; Neuropathic Pain

Treatments: Device: Sham rTMS Protocol; Device: High-frequency real-time rTMS M1 motor cortex protocol; Device: High-frequency real-time rTMS DLPF cortex protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06726954

TMSSCINP

Details and patient eligibility

About

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.

Full description

Spinal cord injury is a disability that causes the loss of many functions for example motor,sensory and autonomic functions in the body. Neuropathic pain is a common problem in participants with spinal cord injury. Many treatment options have been offered for a debilitating condition that has major negative effects on participant's quality of life but provides limited effects and many secondary effects. There is evidence for neuromodulation techniques to improve many pain conditions, such as neuropathic pain. One innovative method for neuropathic pain management, rTMS, is a non-invasive neuromodulation intervention with a low risk of side effects that works by altering brain activity. While most studies to date have mainly targeted the primary motor cortex (M1), fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral prefrontal cortex (DLPFC).

The initial assessment will include answering questionnaires: Brief Pain Inventory, Neuropathic Pain Symptom Inventory(NPSI), International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, Patient Catastrophizing Scale(PCS), Beck Depression Inventory,Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS),Pittsburgh Sleep Quality Index and previous medication and treatment questionnaires.Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment and at 2 months after their last rTMS treatment.

TMS Protocol: Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Daily rTMS sessions will include at a frequency of 10 Hz, treatment intensity will be applied at 120% of the participants resting motor threshold (RMT). A RMT is the minimal intensity required to evoke a motor evoked potential and will be obtained by administering single-pulse TMS to the left motor cortex participant a will be seated in a comfortable chair or their wheelchair for each rTMS session.

Participants with spinal cord injury receiving rTMS in DLPFC or M1 protocol in addition to neurological rehabilitation will be compared with the sham rTMS group in terms of neuropathic pain, sleep quality, depression and quality of life.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups

First Group

Experimental group

Description:

High-frequency real-time rTMS protocol It was planned to apply the dorsolateral prefrontal cortex daily at a frequency of 10 Hz for 20 sessions.

Treatment:

Device: High-frequency real-time rTMS DLPF cortex protocol

Second Group

Experimental group

Description:

High-frequency real-time rTMS protocol It was planned to apply the M1 motor cortex daily at a frequency of 10 Hz for 20 sessions.

Treatment:

Device: High-frequency real-time rTMS M1 motor cortex protocol

Third Group

Sham Comparator group

Description:

Sham rTMS Protocol It was planned to apply daily sham rTMS for 20 sessions.

Treatment:

Device: Sham rTMS Protocol