Clinical trial NCT06215079: Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke
Official title: Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: complex regional pain syndrome
transcranial magnetic stimulation
ischemic stroke
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.

Detailed description: After ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rTMS with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rTMS with conventional rehabilitation, and those undergoing only conventional rehabilitation. The TMS group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke

Exclusion Criteria:

Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
measure: Brunnstrom's Hemiplegia Recovery Staging
timeFrame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
measure: Stroke Specific Quality of Life Scale (SS-QoL)
timeFrame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Secondary outcomes:
measure: Fugl Meyer Upper Extremity Assessment
timeFrame: Before treatment (initial), at the end, four weeks after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Study officials:
References:
citation: Gaertner M, Kong JT, Scherrer KH, Foote A, Mackey S, Johnson KA. Advancing Transcranial Magnetic Stimulation Methods for Complex Regional Pain Syndrome: An Open-Label Study of Paired Theta Burst and High-Frequency Stimulation. Neuromodulation. 2018 Jun;21(4):409-416. doi: 10.1111/ner.12760. Epub 2018 Mar 4.
citation: Chang MC, Kwak SG, Park D. The effect of rTMS in the management of pain associated with CRPS. Transl Neurosci. 2020 Sep 28;11(1):363-370. doi: 10.1515/tnsci-2020-0120. eCollection 2020.
citation: Nardone R, Brigo F, Holler Y, Sebastianelli L, Versace V, Saltuari L, Lochner P, Trinka E. Transcranial magnetic stimulation studies in complex regional pain syndrome type I: A review. Acta Neurol Scand. 2018 Feb;137(2):158-164. doi: 10.1111/ane.12852. Epub 2017 Oct 3.