The Effect of Repetative Transcranial Magnetic Stimulation Therapy for Stroke Patients
1 other identifier
interventional
52
1 country
1
Brief Summary
The aim of our study is to investigate the effect of repetitive transcranial magnetic stimulation therapy (rTMS) on lower urinary system dysfunctions and detrusor muscle activity in stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2022
CompletedFirst Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 22, 2023
February 1, 2023
1.3 years
February 13, 2023
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline Danish Scale at 15th day and 8th week
The questionnaire consists of 12 questions about lower urinary tract symptoms (LUTS). It is a questionnaire study that questions the frequency and severity of their symptoms (symptom score) and its effect on their daily life (discomfort score) from the participants. It is one of the reliable methods that questions the frequency and severity of lower urinary tract symptoms and disturbing factors.
up to 8th week
Change from baseline International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at 15th day and 8th week
Evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. When using the ICIQ-UI SF, an overall ICIQ score in the range of 0-21 is obtained from the first three questions. A score of zero means no urine leakage and no impact on quality of life. Question 1 (Q1) measures the frequency of urinary incontinence, question 2 (Q2) evaluates the amount of leakage, and question 3 (Q3) evaluates how much urinary incontinence affects daily life.
up to 8th week
Secondary Outcomes (6)
Change from baseline Uroflowmetry and residual urine at 15th day and 8th week
up to 8th week
Change from baseline Overactive Bladder Symptom Score (OABSS) at 15th day and 8th week
up to 8th week
Change from baseline Urinary Incontinence Quality Of Life Scale at 15th day and 8th week
up to 8th week
Change from baseline Barthel İndex at 15th day and 8th week
up to 8th week
Change from baseline Beck's Depression Inventory at 15th day and 8th week
up to 8th week
- +1 more secondary outcomes
Study Arms (2)
Low Frequency rTMS Protocol
EXPERIMENTALIt was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex 5 days a week for 3 weeks, for a total of 15 sessions.
Sham rTMS Protocol
PLACEBO COMPARATORIt was planned to apply the recorded beat sound to the primary motor cortex area daily 5 days a week for 3 weeks, for a total of 15 sessions by turning the TMS coil with the reverse side and in a 90-angle upright position.
Interventions
It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex 5 days a week for 3 weeks, for a total of 15 sessions. rTMS application Magventure MagPro R30 device is planned to provide magnetic stimulation with its stimulator. The stimulation pattern was shaped according to the protocols used in previous studies. All patients were planned to continue the neurological rehabilitation program throughout the study. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment they are using and the drugs started for incontinence at the same effective dose, and no new incontinence medication will be started and the dose will not be changed during the rTMS sessions.
It was planned to apply the recorded beat sound to the primary motor cortex area daily 5 days a week for 3 weeks, for a total of 15 sessions by turning the TMS coil with the reverse side and in a 90-angle upright position. All patients were planned to continue the neurological rehabilitation program throughout the study. Along with the daily rTMS session, patients will continue to use the drugs in the medical treatment they are using and the drugs started for incontinence at the same effective dose, and no new incontinence medication will be started and the dose will not be changed during the rTMS sessions.
Eligibility Criteria
You may qualify if:
- A person between the ages of 40-80 who applied to AFSU Physical Medicine and Rehabilitation Clinic with the diagnosis of stroke in the inpatient service or outpatient for neurological rehabilitation,
- Having had a stroke at least three months ago,
- Able to follow two-stage verbal commands and agree to participate in the study voluntarily and regularly,
- Medically stable,
- Neurologically stable,
You may not qualify if:
- Patients with significant comorbidities such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,
- Epilepsy, history of antiepileptic drug use intracranial metal body,
- Having an ear implant,
- Cognitive dysfunction,
- Lower extremity peripheral nerve injury
- Malignancy
- Active infection
- Infection on the skin in the application area, open wound
- İnflammatory disease
- Orthopedic injuries that can limit maximal effort contractions
- Brain lesion or history of drug use that may affect seizure threshold
- İncreased intracranial pressure
- Patients with uncontrolled migraine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200, Turkey (Türkiye)
Related Publications (2)
Jiang W, Tang W, Song Y, Feng Y, Zhou Y, Li L, Tan B. Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial. Trials. 2022 Aug 13;23(1):650. doi: 10.1186/s13063-022-06535-y.
PMID: 35964135RESULTNardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.
PMID: 31541980RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Doctor
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 22, 2023
Study Start
December 2, 2022
Primary Completion
April 1, 2024
Study Completion
June 1, 2024
Last Updated
February 22, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share