Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study

Ege University

Status: Active, not recruiting

Conditions: Postpolio Syndrome

Treatments: Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06926270

1174637

Details and patient eligibility

About

The study is planned to include a minimum of 26 patients with paralytic poliomyelitis who meet the PPS diagnostic criteria (1). Patients will be randomized into two groups, and one group will receive only the exercise therapy used in standard treatment, while the other group will receive Transcranial Magnetic Stimulation (TMS) therapy in addition to exercise. TMS will be applied to the study group 5 times a week for 2 weeks, for a total of 10 sessions. The protocol to be applied during the study will be set to 1 Hz, and each session will last 15 minutes. All participants will be evaluated with muscle strength (manual muscle testing), 6-minute walking test, polio-related problems inventory, VAS pain, VAS fatigue, fatigue severity scale, Beck Depression Inventory, Nottingham health profile scales before, at the end of treatment, and at the end of the 3rd month. As a result of the evaluation, the potential positive effects of TMS on patients with PPS will be measured and evidence-based data for the use of this treatment modality in patients with PPS will be obtained. This study will be the first to evaluate the effectiveness of TMS in a controlled manner in a patient group with PPS. As a result of the evaluation, the potential positive effects of TMS on patients with PPS will be measured and evidence-based data will be obtained for the use of this treatment modality in patients with PPS.

Enrollment: 26 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:-Having been diagnosed with PPS (postpolio syndrome) -Having not received TMS treatment before

Exclusion Criteria:-History of epilepsy

• Presence of another disease that may be associated with the symptoms
• Inability to ambulate independently
• Presence of a neurological, psychiatric or vision-related problem that may prevent the patient from answering the questionnaires
• Presence of ferromagnetic material implanted in the body
• Organic brain pathology (vascular, traumatic, tumoral, etc.)
• History of use of drugs that lower the seizure threshold (if not receiving antiepileptic treatment)
• Severe or recent heart disease
• Alcoholism
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

SHAM

Sham Comparator group

Description:

5 sessions per week; 2 weeks, 90% RMT (resting motor threshold), 1 Hz, 15 min TMS will be applied, but treatment During the procedure, the application head of the device is turned in the opposite direction so that the patient receives TMS treatment. effect, but you hear the operating sound of the device and will spend it in the laboratory Also, home exercise program: quadriceps strengthening and knee isometric exercises

Treatment:

Device: TMS

INTERVENTION

Experimental group

Description:

5 sessions/week, 2 weeks, 90% RMT (resting motor threshold), 1 Hz, 15 min TMS application to patients As the application point, the Cz point on the EEG map, contralateral to the affected extremity, will be taken Also, home exercise program: quadriceps strengthening and knee isometric exercises

Treatment:

Device: TMS