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

Ankara City Hospital

Status: Enrolling

Conditions: Complex Regional Pain Syndromes

Treatments: Device: conventional rehabilitation program; Device: Sham transcranial magnetic stimulation; Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)

Study type: Interventional

Funder types: Other

Identifiers

NCT06215079

10028974

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke

Exclusion criteria

Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups, including a placebo group

active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome

Active Comparator group

Description:

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.

Treatment:

Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)

sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome

Sham Comparator group

Description:

Similar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group.

Treatment:

Device: Sham transcranial magnetic stimulation

conventional rehabilitation program in stroke patients with complex regional pain syndrome

Placebo Comparator group

Description:

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.

Treatment:

Device: conventional rehabilitation program