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Postpolio SyndromeNCT06926270

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

A study testing Repetitive transcranial magnetic stimulation (rTMS) and Individualized home exercise program in people with Postpolio Syndrome, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Postpolio Syndrome
What is being tested?
Repetitive transcranial magnetic stimulation (rTMS) and Individualized home exercise program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2024to 25 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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)
Show all 9Show fewer
  • Severe or recent heart disease
  • Alcoholism
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ege University Faculty of Medicine

    Izmir, BORNOVA, 35100

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Repetitive transcranial magnetic stimulation (rTMS), Sham rTMS, Individualized home exercise program
Keywords
Postpolio, poliomyelit, TMS, rTMS, gait speed
Medical subject headings
Postpoliomyelitis Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive transcranial magnetic stimulation (rTMS)Device

    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.

  • Sham rTMSDrug

    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.

  • Individualized home exercise programBehavioural

    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.

Study groups in NCT06926270
Study groupRoleWhat they receive
Sham rTMSSham comparatorSham stimulation followed the same treatment 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. All participants received an individualized home exercise program 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.
Receives: Drug: Sham rTMS; Behavioral: Individualized home exercise program
Active rTMSExperimentalActive rTMS was delivered using a Magstim Rapid2 stimulator and a figure-of-eight D70 coil (Magstim Company Ltd, Whitland, United Kingdom). The target was the lower-extremity representation of the primary motor cortex near the vertex. Stimulation was delivered at 80% of resting motor threshold, at 1 Hz for 20 minutes (1200 pulses per session), over 10 sessions in 2 weeks. All participants received an individualized home exercise program 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.
Receives: Device: Repetitive transcranial magnetic stimulation (rTMS); Behavioral: Individualized home exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 minute walk test (6MWT)

    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.

    Measured: Baseline, immediately after treatment, and 3-month follow-up

Secondary outcomes (6)
  1. Polio-Related Problems Scale (PRPS)

    The Polio-Related Problems Scale (PRPS) assesses the severity of post-polio-related symptoms and functional problems. Higher scores indicate greater symptom burden and impairment.

    Measured: Baseline, immediately after treatment, and 3-month follow-up

  2. Nottingham health profile (NHP)

    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

    Measured: Baseline, immediately after treatment, and 3-month follow-up

  3. Visual analogue scale (VAS) for pain and fatigue

    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"

    Measured: Baseline, immediately after treatment, and 3-month follow-up

  4. Manual muscle testing (MMT)

    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)

    Measured: Baseline, immediately after treatment, and 3-month follow-up

  5. Fatigue Impact Scale (FIS)

    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.

    Measured: Baseline, immediately after treatment, and 3-month follow-up

  6. Beck Depression Inventory (BDI)

    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).

    Measured: Baseline, immediately after treatment, and 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start1 Oct 2024
  3. Primary completion20 Jun 2025
  4. Study completion25 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926270
Sponsor's protocol ID
1174637
Status last verified
Sep 2026
First submitted
7 Apr 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Altas EU, Askin A, Besiroglu L, Tosun A. Is high-frequency repetitive transcranial magnetic stimulation of the left primary motor cortex superior to the stimulation of the left dorsolateral prefrontal cortex in fibromyalgia syndrome? Somatosens Mot Res. 2019 Mar;36(1):56-62. doi: 10.1080/08990220.2019.1587400. Epub 2019 Apr 8.

    PubMed 30955403
  • Klomjai W, Katz R, Lackmy-Vallee A. Basic principles of transcranial magnetic stimulation (TMS) and repetitive TMS (rTMS). Ann Phys Rehabil Med. 2015 Sep;58(4):208-213. doi: 10.1016/j.rehab.2015.05.005. Epub 2015 Aug 28.

    PubMed 26319963
  • Ertekin C, On AY, Kirazli Y, Kurt T, Gurgor N. Motor evoked responses from the thigh muscles to the stimulation of the upper limb nerves in patients with late poliomyelitis. Clin Neurophysiol. 2002 Apr;113(4):478-84. doi: 10.1016/s1388-2457(02)00043-3.

    PubMed 11955992
  • Willen C, Hou L, Stibrant Sunnerhagen K. A very long-term longitudinal follow-up of persons with late effects of polio. Eur J Phys Rehabil Med. 2020 Apr;56(2):155-159. doi: 10.23736/S1973-9087.20.05918-3. Epub 2020 Feb 10.

    PubMed 32043852
  • Latifoglou E, Cinar E, Tanigor G, On AY. Coexistence of fibromyalgia and post-polio syndrome in persons with prior poliomyelitis in Turkey: the relations with symptoms, polio-related impairments, and quality of life. Disabil Rehabil. 2023 Oct;45(21):3511-3518. doi: 10.1080/09638288.2022.2127931. Epub 2022 Sep 28.

    PubMed 36169616

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive transcranial magnetic stimulation (rTMS) and Individualized home exercise program in people with Postpolio Syndrome, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 minute walk test (6MWT) (time frame: Baseline, immediately after treatment, and 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926270, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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