Clinical trial NCT05645003: Transcranial Magnetic Stimulation Therapy in Neuropathic Painful Spinal Cord Injury Patients
Official title: Effect of Repetative Transcranial Magnetic Stimulation Therapy on Neuropathic Pain in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Neurological Diseases or Conditions
Keywords: Repetitive Transcranial Magnetic Stimulation
Neurological Rehabilitation
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Change from baseline Visual Analog Scale (VAS) at 15 day and 6 week.
timeFrame: up to 6 week
Secondary outcomes:
measure: Change from baseline The Leeds Assessment of Neuropathic Symptoms & Signs Pain Scale(LANSS) at 15 day and 6 week.
timeFrame: up to 6 week
measure: Change from baseline Short form McGill Pain questionnaire(SF-MPQ) at 15 day and 6 week.
timeFrame: up to 6 week
measure: Change from baseline Short form 36 (SF-36) at 15 day and 6 week.
timeFrame: up to 6 week
measure: Change from baseline Beck Depression Scale at 15 day and 6 week.
timeFrame: up to 6 week
measure: Beck Anxiety Scale at 15 day and 6 week.
timeFrame: up to 6 week
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.