Skip to main content
OpenTrials
Completed

NCT Number: NCT06197113

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

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuropathic Pain Behavior Behavioral Symptoms Central Nervous System Diseases Depression Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magstim Rapid2 Magnetic Stimulator

Device

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

Primary outcomes

  1. Change in pain severity and pain interference assessed using the Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 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.

    Brief Pain Inventory-Short Form (BPI-SF) is designed to assess pain in sensory (pain intensity and severity) and reactive dimensions (impact on daily functioning). The BPI-SF consists of two sections. The first section evaluates the intensity of worst, least, average, and current pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates no pain at all quot; and a response of 10 indicates pain as bad as you can imagine. The second section consists of seven questions that assess the impact of pain on general activity, mood, work, walking ability, sleep, relationships with others, and enjoyment of life. Responses are rated on a scale of 0 to 10. A response of 0 in the second section indicates 'does not interfere' and a response of 10 indicates 'completely interferes'. The second section total score is calculated by summing the scores of the seven questions, resulting in a score out of 70. The total score ranges from 0 to 70.

Secondary outcomes

  1. Change in depression severity assessed using the Beck Depression Inventory (BDI)

    Time frame: Patients were evaluated with BDI before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.

    The Beck Depression Inventory (BDI) is one of the most commonly used self-assessment scales to determine the level of depression. It consists of 21 items, each containing 4 options that indicate the level of the individual's mood. The patient selects the most appropriate expression for themselves. Each option is scored from 0 to 3, with 0 indicating the mildest and 3 indicating the most severe symptom. The scores from the 21 questions are added up to calculate the total score. The total score ranges from 0 to 63. It is classified as minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63) depression. The Turkish validity and reliability of the scale were conducted. In this study, the BDI was used to assess the level of depression in patients with SCI.

  2. Patient-reported treatment satisfaction assessed using a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied)

    Time frame: It was administered immediately after the end of treatment and 4 weeks after the end of treatment.

    Patient satisfaction with treatment was evaluated using a 5-point Likert scale. 1 represented 'not satisfied at all' and 5 represented very satisfied.

  3. Treatment-related discomfort assessed using a 10-cm Visual Analog Scale (VAS; 0 = no discomfort, 10 = worst imaginable discomfort)

    Time frame: It was administered immediately after the end of treatment.

    4.The level of discomfort caused by the treatment was evaluated using the Visual Analog Scale (VAS). In this scale, the two ends of a 10 cm line are labeled with the extreme descriptions of the parameter to be evaluated. Although this scale is commonly used for pain assessment, it was used in our study to assess the level of discomfort. The scale ranges from 0 (no discomfort) to 10 (the most severe discomfort the patient has ever experienced in their life), and the patient is asked to mark the region that corresponds to their current condition. The distance of the marked point from the 0 point determines the patient level of discomfort.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.