Transcranial Magnetic Stimulation Therapy in Neuropathic Painful Spinal Cord Injury Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-frequency real-time rTMS protocol, Sham rTMS Protocol.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Neuropathic Pain, Neurological Diseases or Conditions. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Repetative Transcranial Magnetic Stimulation Therapy on Neuropathic Pain in Patients With Spinal Cord Injury
Overview
The aim of our study is to investigate the effect of high-frequency Repetitive Transcranial Magnetic Stimulation(rTMS) therapy applied to the dorsolateral PFC (DLPFC) area on neuropathic pain in patients with spinal cord injury. In this area, there are very few studies on the effectiveness of rTMS treatment added to medical treatment in neuropathic pain. In addition, the number of studies comparing the effect of rTMS therapy applied to the DLFPC area is very few.
Detailed description
Spinal cord injury (SCI) is associated with widespread disability due to its detrimental effects on various bodily functions. Neuropathic pain is one of the most challenging complications after SCI and can have a significant impact on daily life.
There are supportive criteria for the diagnosis of neuropathic pain associated with SCI: onset of pain within one year after SCI, absence of primary association between pain with movement, inflammation or other local tissue damage, burning, tingling, pins and needles, throbbing pain, squeezing pain, Detection of 1 or more of the pain descriptors such as freezing pain, allodynia or hyperalgesia within the pain distribution support neuropathic pain due to spinal cord injury.
Pharmacological and interventional treatments are often tried in the treatment of neuropathic pain, but their success is often limited. Another option that has been used as an innovative approach in the treatment of neuropathic pain in recent years is pain regulation with rTMS. As one of the non-invasive brain stimulation techniques, rTMS is suggested to be useful in the treatment of central neuropathic pain. While most studies to date have mainly targeted the primary motor cortex (M1), which is contralateral to the pain side, fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral PFC (DLPFC). The analgesic mechanisms of rTMS to the DLPFC are thought to be through the same mechanism as stimulation of the M1 motor cortex.
The aim of our study; To investigate the effect of high frequency rTMS applications on patients with SCI on their neuropathic pain.
Interventions
- Device High-frequency real-time rTMS protocol
It was planned to apply a total of 1200 beats to the dorsolateral prefrontal cortex daily for 15 sessions. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment (pregabalin, gabapentin, carbamazepine) at the same effective dose. No dose changes will be made during rTMS sessions. - Device Sham rTMS Protocol
It was planned to apply a to the dorsolateral prefrontal cortex daily for 15 sessions. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment (pregabalin, gabapentin, carbamazepine) at the same effective dose. No dose changes will be made during rTMS sessions.
Primary outcome measures
- Change from baseline Visual Analog Scale (VAS) at 15 day and 6 week. [Time frame: up to 6 week]
Secondary outcome measures (5)
- Change from baseline The Leeds Assessment of Neuropathic Symptoms & Signs Pain Scale(LANSS) at 15 day and 6 week. [Time frame: up to 6 week]
- Change from baseline Short form McGill Pain questionnaire(SF-MPQ) at 15 day and 6 week. [Time frame: up to 6 week]
- Change from baseline Short form 36 (SF-36) at 15 day and 6 week. [Time frame: up to 6 week]
- Change from baseline Beck Depression Scale at 15 day and 6 week. [Time frame: up to 6 week]
- Beck Anxiety Scale at 15 day and 6 week. [Time frame: up to 6 week]
Eligibility criteria
Inclusion criteria
Between the ages of 20-70, who applied to the AFSU Physical Medicine and Rehabilitation inpatient service with the diagnosis of spinal cord injury and
- Having spinal cord injury with neurophatic pain at least six months ago,
- Able to follow two-stage verbal commands,
- Agreeing to participate in the study voluntarily and regularly,
- Patients who are medically stable (no previous myocardial infarction, no musculoskeletal problems) will be included in our study.
Exclusion criteria
Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,
- Epilepsy,
- History of antiepileptic drug use,
- Intracranial metal object,
- Presence of in-ear implant,
- Cognitive dysfunction,
- Lower extremity peripheral nerve injury,
- With malignancy and active infection,
- Infection on the skin in the application area,
- Having an open wound,
- Having inflammatory disease,
- Orthopedic injuries that can limit maximum effort contractions,
- Having a brain lesion or a history of drug use that will affect the seizure threshold,
- Patients with increased intracranial pressure or uncontrolled migraine will not be included.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Afyonkarahisar — Afyonkarahisar
Publications
- Nardone R, Holler Y, Langthaler PB, Lochner P, Golaszewski S, Schwenker K, Brigo F, Trinka E. rTMS of the prefrontal cortex has analgesic effects on neuropathic pain in subjects with spinal cord injury. Spinal Cord. 2017 Jan;55(1):20-25. doi: 10.1038/sc.2016.87. Epub 2016 May 31. PMID 27241450
- Yang QH, Zhang YH, Du SH, Wang YC, Fang Y, Wang XQ. Non-invasive Brain Stimulation for Central Neuropathic Pain. Front Mol Neurosci. 2022 May 19;15:879909. doi: 10.3389/fnmol.2022.879909. eCollection 2022. PMID 35663263
- Li L, Huang H, Yu Y, Jia Y, Liu Z, Shi X, Wang F, Zhang T. Non-invasive Brain Stimulation for Neuropathic Pain After Spinal Cord Injury: A Systematic Review and Network Meta-Analysis. Front Neurosci. 2022 Feb 11;15:800560. doi: 10.3389/fnins.2021.800560. eCollection 2021. PMID 35221889
Identifiers
NCT: NCT05645003 · TMSSKY2022