Clinical trial NCT06926270: Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study
Official title: Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpolio Syndrome
Keywords: Postpolio
poliomyelit
TMS
rTMS
gait speed
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:-Having been diagnosed with PPS (postpolio syndrome) -Having not received TMS treatment before

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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

Primary outcomes:
measure: 6 minute walk test
timeFrame: 2 weeks
Secondary outcomes:
measure: Self-reported ımpairments in persons with late effects of polio (SIPP) rating scale
timeFrame: 2 weeks
measure: Nottingham health profile (NHP)
timeFrame: 2 weeks
measure: Visual analogue scale (VAS) for pain and fatigue
timeFrame: 2 weeks
measure: Manual muscle testing (MMT)
timeFrame: 2 weeks
measure: Fatigue Impact Scale (FIS)
timeFrame: 2 weeks
measure: Beck Depression Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: Ege University Faculty of Medicine
state: Bornova
Study officials:
affiliation: Ege Universtiy
name: Arzu On, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.