Ege University Faculty of Medicine
Izmir, BORNOVA, 35100, Turkey (Türkiye)
NCT Number: NCT06926270
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.
Looking for future studies?
Notify Me25 year–65 year
All sexes
Interventional
Not applicable
Izmir, BORNOVA, 35100, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Having been diagnosed with PPS (postpolio syndrome) -Having not received TMS treatment before
-
Exclusion criteria
-History of epilepsy
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 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.
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.
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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.
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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"
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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)
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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.
Time frame: Baseline, immediately after treatment, and 3-month follow-up
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).
Looking for future studies?
Notify MeEge University
Other
Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study
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