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

Not Applicable

Active, not recruiting

• Conditions: Postpolio Syndrome

• Registration Number: NCT06926270
• Lead Sponsor: Ege University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-12-25
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6 minute walk test	2 weeks	It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.

Secondary Outcome Measures

Name	Time	Method
Self-reported ımpairments in persons with late effects of polio (SIPP) rating scale	2 weeks	It consists of 13 items about PRI that the participants might have been bothered during the past 2 weeks: muscle weakness, muscle fatigue, muscle, and/or joint pain during physical activity and at rest, sensory disturbance, breathing difficulties at rest and during physical activity, cold intolerance, general fatigue, sleep disturbances, concentration difficulties, memory difficulties, and mood swings. The respondents are asked to rate each item as; 1: not at all, 2: little, 3: quite a bit 4: extremely, giving a total sum score ranging from 13 to 52 points. A higher score indicates more self-reported impairments
Nottingham health profile (NHP)	2 weeks	It consists of 38 items assessing how severe an impact the respondent thinks their health is having on six dimensions: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. Every item has a different weight, depending on the severity of the symptom. The sum of the weighted scores is 100 for each subdimension. Thus, summing all weighted values of every item, the score between 0 and 100 is obtained for each subdimension. The total score was obtained by summing the scores of six subdimensions, giving the values between 0 and 600. Higher scores indicate a greater level of distress
Visual analogue scale (VAS) for pain and fatigue	2 weeks	Severity of pain that the participants have had in the past week was evaluated by using visual analogue scale (VAS) on a 10-cm horizontal line where 0-cm represented "no pain" and 10 cm the "worst imaginable pain"; Severity of fatigue experienced by the participants in the past week was assessed by using VAS on a 10-cm horizontal line where 0-cm represented "not tired at all" and 10-cm "extremely tired"
Manual muscle testing (MMT)	2 weeks	Muscle strength of the hip flexors, knee extensors, knee flexors, ankle dorsiflexors, and plantar flexors were measured bilaterally according to the Medical Research Council Scale . A sum score (manual muscle testing \[MMT\] sum) was obtained by adding the scores of all muscle groups tested (max score: 50)
Fatigue Impact Scale (FIS)	2 weeks	Cognitive, functional and fatigue subscales are available and high scores are associated with poor fatigue level
Beck Depression Scale	2 weeks	The Beck depression test is used to measure how intensely depressed a person is during a 1-week period.21 questions; each question is scored between 0 and 3. The degree of depression is determined according to the total score (0-9: minimal depression, 10-16: mild depression, 17-29: moderate depression, 30-63: severe depression).

Trial Locations

Locations (1)

Ege University Faculty of Medicine; 🇹🇷 İ̇zmi̇r, Bornova, Turkey