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Neuropathic PainNCT06197113

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

A study testing Magstim Rapid2 Magnetic Stimulator in people with Neuropathic Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neuropathic Pain
What is being tested?
Magstim Rapid2 Magnetic Stimulator
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2022to 11 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Bilkent City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

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

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?

Read the 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.

Being tested
Magstim Rapid2 Magnetic Stimulator
Keywords
Repetitive Transcranial Magnetic Stimulation, Intermittent Teta Burst Stimulation, Spinal cord injury, Depression, Pain
Medical subject headings
Neuralgia, Spinal Cord Injuries, Depression, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magstim Rapid2 Magnetic StimulatorDevice

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

Study groups in NCT06197113
Study groupRoleWhat they receive
10 Hz rTMS groupActive comparatorTo 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.
Receives: Device: Magstim Rapid2 Magnetic Stimulator
iTBS groupActive comparatorTo 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.
Receives: Device: Magstim Rapid2 Magnetic Stimulator
Sham GroupSham comparatorThe patients in the sham group (n:8) were given sham stimulation with a sham coil for 10 sessions.
Receives: Device: Magstim Rapid2 Magnetic Stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 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 (3)

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

    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.

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

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

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

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

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

    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.

    Measured: It was administered immediately after the end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start1 Jul 2022
  3. Primary completion11 Jul 2023
  4. Study completion11 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06197113
Sponsor's protocol ID
AnkaraCHBilkent_ozgearar
Status last verified
Dec 2023
First submitted
26 Dec 2023
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siddall PJ. Management of neuropathic pain following spinal cord injury: now and in the future. Spinal Cord. 2009 May;47(5):352-9. doi: 10.1038/sc.2008.136. Epub 2008 Nov 11.

    PubMed 19002150

  • Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

    PubMed 31901449

  • Andre-Obadia N, Magnin M, Garcia-Larrea L. Theta-burst versus 20 Hz repetitive transcranial magnetic stimulation in neuropathic pain: A head-to-head comparison. Clin Neurophysiol. 2021 Oct;132(10):2702-2710. doi: 10.1016/j.clinph.2021.05.022. Epub 2021 Jun 20.

    PubMed 34217600

  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PubMed 8080219

  • Yildirim Y, Parlar Kilic S, Eyigor S, Eyigor C, Yildirim Y, Karaman E, Oyur Celik G, Uyar M. Validity and reliability of Turkish version of the Brief Pain Inventory-Short Form for patients with chronic nonmalignant pain. Agri. 2019 Nov;31(4):195-201. doi: 10.14744/agri.2019.25901.

    PubMed 31741339

  • Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239.

    PubMed 9636945

  • Herwig U, Satrapi P, Schonfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003 Winter;16(2):95-9. doi: 10.1023/b:brat.0000006333.93597.9d.

    PubMed 14977202

  • Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.

    PubMed 12849236

  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

    PubMed 15664172

Questions about this trial

What is this clinical trial studying?

A study testing Magstim Rapid2 Magnetic Stimulator in people with Neuropathic Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06197113, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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