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).
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
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.
- Conditions
- Postpolio 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 group | Role | What they receive |
|---|---|---|
| Sham rTMS | Sham comparator | Sham 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 rTMS | Experimental | Active 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.
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)
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
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
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
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
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
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.
- First posted13 Apr 2025
- Study start1 Oct 2024
- Primary completion20 Jun 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postpolio SyndromeStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu On, Ege University
- Investigators
- Arzu On, Prof.Dr, Principal investigator, Ege Universtiy
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 30955403Klomjai 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 26319963Ertekin 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 11955992Willen 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 32043852Latifoglou 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT06926270
- Acronym / sponsor ID
- 1174637
- Conditions
- Postpolio Syndrome
- Keywords
- Postpolio, poliomyelit, TMS, rTMS, gait speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS | Sham comparator | Drug: Sham rTMS, Behavioral: Individualized home exercise programSham 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. |
| Active rTMS | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS), Behavioral: Individualized home exercise programActive 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive 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. | Device | Active rTMS |
| Sham rTMSSham 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. | Drug | Sham rTMS |
| Individualized home exercise programAn 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. | Behavioural | Active rTMS, Sham rTMS |
Primary outcome
6 minute walk test (6MWT)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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.
6 secondary outcomes
Polio-Related Problems Scale (PRPS)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
Nottingham health profile (NHP)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
Visual analogue scale (VAS) for pain and fatigue
Time frame: Baseline, immediately after treatment, and 3-month follow-up
Manual muscle testing (MMT)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
Fatigue Impact Scale (FIS)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
Beck Depression Inventory (BDI)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 30955403Altas 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.
- Background: PubMed 26319963Klomjai 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.
- Background: PubMed 11955992Ertekin 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.
- Background: PubMed 32043852Willen 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.
- Background: PubMed 36169616Latifoglou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arzu On, Prof.Dr principal investigator
Ege Universtiy
1 site in 1 country: see every site and its status.
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.