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

NCT06926270 | Completed

• 1 other identifier: 1174637
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpolio Syndrome

Keywords

Postpolio; poliomyelit; TMS; rTMS; gait speed

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test

  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 Outcomes (6)

• Self-reported ımpairments in persons with late effects of polio (SIPP) rating scale

  2 weeks

• Nottingham health profile (NHP)

  2 weeks

• Visual analogue scale (VAS) for pain and fatigue

  2 weeks

• Manual muscle testing (MMT)

  2 weeks

• Fatigue Impact Scale (FIS)

  2 weeks

Study Arms (2)

SHAM

SHAM COMPARATOR

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

INTERVENTION

EXPERIMENTAL

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

Interventions

TMS DEVICE

Magstim ,Rapid 2

INTERVENTION; SHAM

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmir, BORNOVA, 35100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30955403 BACKGROUND

• 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.

  PMID: 26319963 BACKGROUND

• 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.

  PMID: 11955992 BACKGROUND

• 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.

  PMID: 32043852 BACKGROUND

• 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.

  PMID: 36169616 BACKGROUND

MeSH Terms

Conditions

Postpoliomyelitis Syndrome

Condition Hierarchy (Ancestors)

Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Arzu On, Prof.Dr

  Ege Universtiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: January 1, 2024
• Primary Completion: December 25, 2024
• Study Completion: April 7, 2025
• Last Updated: April 9, 2026

Record last verified: 2025-04

Locations

TU (1)