Clinical trial NCT06197113: Teta Burst Versus 10 Hz Repetitive Transcranial Magnetic Stimulation İn Neuropathic Pain: A Sham Controlled Comparison
Official title: Comparison Of The Efficacies Of Intermittent Teta Burst And 10 Hz Repetitive Transcranial Magnetic Stimulation In The Treatment Of Neuropathic Pain In Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Repetitive Transcranial Magnetic Stimulation
Intermittent Teta Burst Stimulation
Spinal cord injury
Depression
Pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neuropathic pain is a common complication after spinal cord injury (SCI), which significantly affects the patient's quality of life and may be resistant to pharmacological treatment. In our study, we aimed to evaluate the efficacies of intermittent theta burst (iTBS) and high frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) by comparing them with each other and with sham stimulation, in the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI.

Question 1: İs rTMS anda iTBS treatment, useful for pain severity and the effect of pain on daily functions, in the treatment of neuropathic pain in SCI Question 2: Are rTMS and iTBS treatments effective in depression in patients with neuropathic pain after spinal cord injury?

Detailed description: Pharmacological treatments may be insufficient to limit neuropathic pain. Therefore, research continues for safe and effective new treatments. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the motor area to which it is applied. Theta Burst stimulation (TBS) is a new rTMS method consisting of stimulation sequences in a special pattern. It stands out with its ability to deliver high pulses in a short time and its high capacity to induce cortical plasticity. Intermittent TBS (iTBS) and high frequency rTMS facilitate excitability in the motor area where it is applied, and this effect is used in pain treatment. Pain modulation with these methods has been tried in some studies. Therefore, repetitive magnetic stimulation of the motor cortex by these two methods may be good options for the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65,
* Traumatic/Non-traumatic spinal cord injury (\>4 months),
* For \>3 months, despite pharmacological treatment (no dose or medication changes have been made for at least 1 month), Brief Pain Inventory (BPI)-Part 1 average pain score is ≥4/10, neuropathic pain at the injury level and/or below (DN4 ≥4 /10) patients

Exclusion Criteria:

* Pain attributed to causes other than neuropathic pain (e.g. musculoskeletal pain, pain resulting from diabetic polyneuropathy), Having a history of epilepsy, dementia, cognitive impairment, neurodegenerative disease,
* Having a history of psychiatric illness (except reactive depression),
* Having a lesion in the brain due to vascular, traumatic, tumoral or infectious reasons,
* Having a history of alcoholism,
* Having an intracranial metallic implant,
* Having a cardiac pacemaker,
* Pregnant patients

Primary outcomes:
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: Patients were evaluated with BPI-SF before the treatment, at the end of the treatment (within the first 24 hours after the 10th session) and 4 weeks after the end of the treatment.
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Patients were evaluated with BDI before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.
measure: Patient satisfaction
timeFrame: It was administered immediately after the end of treatment and 4 weeks after the end of treatment.
measure: The level of discomfort
timeFrame: It was administered immediately after the end of treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
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