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
NCT ID: NCT06215079
Last Updated: 2024-01-22
Study Results
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Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-11-15
2024-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome
The intermittent theta-burst stimulation (iTBS) intensity for patients, applied under doctor supervision for a total of 5 days over one week (from Monday to Friday), will be set at 70% of the resting motor threshold. Stimulation will consist of bursts at a frequency of 50 Hz, with 3 bursts every 10 seconds, each burst lasting 2 seconds, totaling 600 bursts. Subsequently, the resting motor threshold will be adjusted to 80%, and a total of 2000 bursts will be delivered at a frequency of 10 Hz, repeated every 30 seconds, each lasting 10 seconds.
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the targeted motor area. While single-pulse TMS is generally used to explore the functioning of the brain, repetitive TMS is employed to induce lasting changes in brain activity. High-frequency rTMS leads to an increase in excitability in the motor cortex, whereas low-frequency application results in inhibition of motor cortical excitability. Theta-burst stimulation (TBS) is a form of rTMS that can be delivered continuously (cTBS) or intermittently (iTBS), thus modulating the excitability of corticospinal neurons beneath the stimulation area to either decrease or increase. rTMS is a growing research area in pain management, proven to be a safe and well-tolerated method. Studies have shown that rTMS applied to the motor cortex is a promising treatment method for chronic pain
sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome
Similar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group.
Sham transcranial magnetic stimulation
Patients in the control group will receive sham transcranial magnetic stimulation with sham coil for 35 minutes a day, 5 sessions in total, together with conventional rehabilitation.
conventional rehabilitation program in stroke patients with complex regional pain syndrome
Only a conventional rehabilitation program consisting of discontinuous ultrasound, transcutaneous electrical nerve stimulation (TENS), and contrast bath, formed by 5 sessions, will be applied to this group.
conventional rehabilitation program
Patients will receive 5 minutes of continuous ultrasound (1MHz, 2W/cm2, 1:4)), followed by a 20-minute contrast bath, and 15 minutes of TENS (frequency: 100 Hz; pulse duration: 50-100 ms; and amplitude adjusted to avoid discomfort or muscle contraction to the patient).
Interventions
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The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the targeted motor area. While single-pulse TMS is generally used to explore the functioning of the brain, repetitive TMS is employed to induce lasting changes in brain activity. High-frequency rTMS leads to an increase in excitability in the motor cortex, whereas low-frequency application results in inhibition of motor cortical excitability. Theta-burst stimulation (TBS) is a form of rTMS that can be delivered continuously (cTBS) or intermittently (iTBS), thus modulating the excitability of corticospinal neurons beneath the stimulation area to either decrease or increase. rTMS is a growing research area in pain management, proven to be a safe and well-tolerated method. Studies have shown that rTMS applied to the motor cortex is a promising treatment method for chronic pain
Sham transcranial magnetic stimulation
Patients in the control group will receive sham transcranial magnetic stimulation with sham coil for 35 minutes a day, 5 sessions in total, together with conventional rehabilitation.
conventional rehabilitation program
Patients will receive 5 minutes of continuous ultrasound (1MHz, 2W/cm2, 1:4)), followed by a 20-minute contrast bath, and 15 minutes of TENS (frequency: 100 Hz; pulse duration: 50-100 ms; and amplitude adjusted to avoid discomfort or muscle contraction to the patient).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Özlem Yücealp
Research Assistant in Physical Medicine and Rehabilitation
Locations
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Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
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https://pubmed.ncbi.nlm.nih.gov/29504190/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711855/
Other Identifiers
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10028974
Identifier Type: -
Identifier Source: org_study_id
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