Teta Burst Versus 10 Hz Repetitive Transcranial Magnetic Stimulation İn Neuropathic Pain: A Sham Controlled Comparison

NCT ID: NCT06197113

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-07-11

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 Hz rTMS group

To the patients in the high frequency (10 Hz) rTMS (n:9) group, 110% resting motor threshold (rMT), 10 Hz frequency stimulation, 5-second stimulation, and then a total of 30 trains and 1500 pulses at 25-second intervals were applied for 15 minutes while targeting the lower extremity motor area.

Group Type: ACTIVE_COMPARATOR

Magstim Rapid2 Magnetic Stimulator

Intervention Type: DEVICE

For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.

iTBS group

To the patients in iTBS group (n:9), three bursts of stimulation at 50 Hz, repeated every 200 milliseconds, were delivered for 2 seconds every 10 seconds, totaling 600 stimuli at MT intensity, applied for a duration of 200 seconds.10 sessions was applied while targeting the lower extremity motor area.

Group Type: ACTIVE_COMPARATOR

Magstim Rapid2 Magnetic Stimulator

Intervention Type: DEVICE

For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.

Sham Group

The patients in the sham group (n:8) were given sham stimulation with a sham coil for 10 sessions.

Group Type: SHAM_COMPARATOR

Magstim Rapid2 Magnetic Stimulator

Intervention Type: DEVICE

For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.

Interventions

Magstim Rapid2 Magnetic Stimulator

For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Özge Büşra Arar Batur

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

AnkaraCHBilkent_ozgearar

Identifier Type: -

Identifier Source: org_study_id