Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome

April 6, 2026 updated by: Arzu On, Ege University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • BORNOVA
      • Izmir, BORNOVA, Turkey (Türkiye), 35100
        • Ege University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: SHAM

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
Device: TMS
Magstim ,Rapid 2
Experimental: INTERVENTION

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
Device: TMS
Magstim ,Rapid 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk test
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported ımpairments in persons with late effects of polio (SIPP) rating scale
Time Frame: 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
2 weeks
Nottingham health profile (NHP)
Time Frame: 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
2 weeks
Visual analogue scale (VAS) for pain and fatigue
Time Frame: 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"
2 weeks
Manual muscle testing (MMT)
Time Frame: 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)
2 weeks
Beck Depression Scale
Time Frame: 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).
2 weeks
Fatigue Impact Scale (FIS)
Time Frame: 2 weeks
Cognitive, functional and fatigue subscales are available and high scores are associated with poor fatigue level. The scale is scored from 0 to 120 points.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Arzu On, Prof.Dr, Ege Universtiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 25, 2024

Study Completion (Actual)

April 7, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1174637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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