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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06926270
Enrollment
28
Registered
2025-04-13
Start date
2024-10-01
Completion date
2025-07-25
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpolio Syndrome

Keywords

Postpolio, poliomyelit, TMS, rTMS, gait speed

Brief summary

This randomized, double-blind, sham-controlled trial evaluated the effects of low-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex on walking capacity, fatigue, post-polio-related symptoms, and health-related quality of life in participants with post-polio syndrome.

Interventions

DEVICERepetitive transcranial magnetic stimulation (rTMS)

Active rTMS was delivered using a Magstim Rapid2 stimulator and a figure-of-eight D70 coil. Stimulation was applied over the lower-extremity representation of the primary motor cortex near the vertex at 1 Hz and 80% of the resting motor threshold for 20 minutes (1200 pulses per session), for 10 sessions over 2 weeks.

DRUGSham rTMS

Sham stimulation followed the same schedule as active rTMS, with the coil reversed and the device operated at minimum output, providing auditory input without effective cortical stimulation. Ten sessions were administered over 2 weeks.

An individualized home exercise program was prescribed based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and outcome assessors were blinded. The investigator administering stimulation was aware of allocation because of coil orientation.

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6 minute walk test (6MWT)Baseline, immediately after treatment, and 3-month follow-upIt 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

MeasureTime frameDescription
Polio-Related Problems Scale (PRPS)Baseline, immediately after treatment, and 3-month follow-upThe Polio-Related Problems Scale (PRPS) assesses the severity of post-polio-related symptoms and functional problems. Higher scores indicate greater symptom burden and impairment.
Nottingham health profile (NHP)Baseline, immediately after treatment, and 3-month follow-upIt 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 fatigueBaseline, immediately after treatment, and 3-month follow-upSeverity 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)Baseline, immediately after treatment, and 3-month follow-upMuscle 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)Baseline, immediately after treatment, and 3-month follow-upCognitive, functional and fatigue subscales are available and high scores are associated with poor fatigue level. The scale is scored from 0 to 120 points.
Beck Depression Inventory (BDI)Baseline, immediately after treatment, and 3-month follow-upThe 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).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORArzu On, Prof.Dr

Ege Universtiy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026