Spinal Cord InjuriesNCT06726954
Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain
A study testing High-frequency real-time rTMS DLPF cortex protocol and High-frequency real-time rTMS M1 motor cortex protocol in people with Spinal Cord Injuries and Neuropathic Pain, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- High-frequency real-time rTMS DLPF cortex protocol and High-frequency real-time rTMS M1 motor cortex protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2024to 30 Dec 2026
- Phase
- Interventional
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years Physician-diagnosed spinal cord injury for at least 3-months Neuropathic pain for at least 3-months Pain not attributable to any other conditions
Who cannot join
- Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, uncontrolled hypertension,arrhythmia, pacemaker)
- Neurodegenerative disease
- Epilepsy
- History of antiepileptic drug use
- Cognitive dysfunction
- Lower extremity peripheral nerve injury
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- Increased intracranial pressure or uncontrolled migraine
- Infection on the skin in the application area.
- Having a brain lesion or a history of drug use that will affect the seizure threshold.
- Any TMS-related contraindications, for example:
- Pacemaker
- Metallic implant
- Previous seizure
- Psychiatric disorders (excluding depression and anxiety)
- Malignancy
- Current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, 0300
Ayşe Kalender, MD, +905389563559, aysebuber007@gmail.com
About this study
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation Therapy in Neuropathic Pain Associated With Spinal Cord Injury; Randomized Controlled Trial
The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.
Read the detailed description
Spinal cord injury is a disability that causes the loss of many functions for example motor,sensory and autonomic functions in the body. Neuropathic pain is a common problem in participants with spinal cord injury. Many treatment options have been offered for a debilitating condition that has major negative effects on participant's quality of life but provides limited effects and many secondary effects. There is evidence for neuromodulation techniques to improve many pain conditions, such as neuropathic pain. One innovative method for neuropathic pain management, rTMS, is a non-invasive neuromodulation intervention with a low risk of side effects that works by altering brain activity. While most studies to date have mainly targeted the primary motor cortex (M1), fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral prefrontal cortex (DLPFC).
The initial assessment will include answering questionnaires: Brief Pain Inventory, Neuropathic Pain Symptom Inventory(NPSI), International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, Patient Catastrophizing Scale(PCS), Beck Depression Inventory,Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS),Pittsburgh Sleep Quality Index and previous medication and treatment questionnaires.Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment and at 2 months after their last rTMS treatment.
TMS Protocol: Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Daily rTMS sessions will include at a frequency of 10 Hz, treatment intensity will be applied at 120% of the participants resting motor threshold (RMT). A RMT is the minimal intensity required to evoke a motor evoked potential and will be obtained by administering single-pulse TMS to the left motor cortex participant a will be seated in a comfortable chair or their wheelchair for each rTMS session.
Participants with spinal cord injury receiving rTMS in DLPFC or M1 protocol in addition to neurological rehabilitation will be compared with the sham rTMS group in terms of neuropathic pain, sleep quality, depression and quality of life.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- High-frequency real-time rTMS DLPF cortex protocol, High-frequency real-time rTMS M1 motor cortex protocol, Sham rTMS Protocol
- Keywords
- Transcranial Magnetic Stimulation, Spinal Cord Injury, Neuropathic Pain
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency real-time rTMS DLPF cortex protocolDevice
It was planned to apply the dorsolateral prefrontal cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
High-frequency real-time rTMS M1 motor cortex protocolDevice
It was planned to apply the M1 motor cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
Sham rTMS ProtocolDevice
It was planned to apply the daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
| Study group | Role | What they receive |
|---|---|---|
| First Group | Experimental | High-frequency real-time rTMS protocol It was planned to apply the dorsolateral prefrontal cortex daily at a frequency of 10 Hz for 20 sessions. Receives: Device: High-frequency real-time rTMS DLPF cortex protocol |
| Second Group | Experimental | High-frequency real-time rTMS protocol It was planned to apply the M1 motor cortex daily at a frequency of 10 Hz for 20 sessions. Receives: Device: High-frequency real-time rTMS M1 motor cortex protocol |
| Third Group | Sham comparator | Sham rTMS Protocol It was planned to apply daily sham rTMS for 20 sessions. Receives: Device: Sham rTMS Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Brief Pain Inventory-Short Form (BPI-SF) at 1. and 2 months.
The Brief Pain Inventory Short Form (SPI-SF) is designed to examine pain in terms of sensory (pain intensity) and impact on daily functioning. The BPI-SF consists of two parts. The first part assesses the severity of worst, mildest, average and momentary pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates "no pain at all" and a response of 10 indicates "the most severe pain imaginable". The second part consists of seven questions assessing how much pain affects daily functioning, including general activity and enjoyment of life. A response of 0 indicates "not at all affected" and a response of 10 indicates "completely affected". The total score ranges from 0-70. Higher scores indicate worsening symptoms.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Secondary outcomes (8)
Change from baseline International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version at 1. and 2 months.
Pain profile, including location, intensity, and interference over the past 7 days will be assessed using the ISCIPBDS self-report tool. All variables are rated on a scale ranging from 0 (no pain at all) to 10(the most severe pain imaginable).Higher scores indicate higher pain intensity.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change from baseline Quality of Life Index Spinal Cord Injury version (QLI-SCI) at 1. and 2 months.
Quality of life and satisfaction with aspects of quality of life will be assessed using the QLI-SCI instrument. This questionnaire focuses on the categories of health and functioning, social and economic, psychological/spiritual, and family. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10(completely satisfied) with a total of 40 points. Higher scores indicates better quality of life.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change from baseline Pain Catastrophizing Scale (PCS) at 1. and 2 months.
Pain experience will be assessed using the PCS. Participants are asked to rate how much they agree with the listed thoughts and feelings they may have when experiencing pain from 0 (not at all) to 4 (all the time). The total score ranges from 0-52. Higher scores indicate increase level of catastrophizing.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change from baseline Beck Depression Inventory (BDI) Scores at 1. and 2 months.
Validated measure of clinical depression symptoms to quantify and track mood over time. Scores index depression severity and range from 0-63: 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.Total score is 63. Higher scores indicates depressive mood.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change in the Patient's Global Impression of Change (PGIC) observed at 1 month and 2 months.
Standardized assessment to assess participants overall impression of improvement. Scores range from 1 to 7, with 1 representing "no change" and 7 representing "a great deal better"
Measured: To be assessed after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change from baseline Neuropathic Pain Symptom Inventory (NPSI) at 1.and 2 months.
An 11-point NRS assess average neuropathic pain severity over the last week. The scale ranged from 0 to 10, with 0 representing "no pain" and 10 representing "the most intense pain imaginable". The NPSI is comprised of five subscales: burning spontaneous pain (burning), pressing spontaneous pain (pressing), paroxysmal pain (paroxysmal), evoked pain (evoked), and paresthesia/dysesthesia. Full scale from 0-10, with higher score indicating more symptom.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 1. and 2 months.
The Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire that assesses sleep quality and disturbances over the past month. The investigators will use the 3-factor scoring, which has been shown to have superior psychometric properties.
The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Change from baseline Modified Ashworth Scale (MAS) at 1. and 2 months.
Modified Ashworth Scale (MAS) will measure spasticity in the limbs. Higher scores represent spasticity or increased resistance to passive movement. All variables are rated on a scale ranging from 0 to 5: 0 means no increase in muscle tone (better outcome) and 5 means rigid (worse outcome).
Measured: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start16 Dec 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Eyvaz, Afyonkarahisar Health Sciences University
- Investigators
- Nuran Eyvaz, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726954
- Sponsor's protocol ID
- TMSSCINP
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208.
PubMed 34196698Lefaucheur 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 31901449Saleh C, Ilia TS, Jaszczuk P, Hund-Georgiadis M, Walter A. Is transcranial magnetic stimulation as treatment for neuropathic pain in patients with spinal cord injury efficient? A systematic review. Neurol Sci. 2022 May;43(5):3007-3018. doi: 10.1007/s10072-022-05978-0. Epub 2022 Mar 3.
PubMed 35239053