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

December 26, 2023 updated by: Özge Büşra Arar Batur, Ankara City Hospital Bilkent

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Magstim Rapid2 Magnetic Stimulator
For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.
Active Comparator: 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.
Device: Magstim Rapid2 Magnetic Stimulator
For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.
Sham Comparator: Sham Group
The patients in the sham group (n:8) were given sham stimulation with a sham coil for 10 sessions.
Device: Magstim Rapid2 Magnetic Stimulator
For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients were evaluated with BDI before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.
Patient satisfaction
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.
It was administered immediately after the end of treatment and 4 weeks after the end of treatment.
The level of 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.
It was administered immediately after the end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

July 11, 2023

Study Completion (Actual)

July 11, 2023

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent_ozgearar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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