Clinical trial NCT05738863: The Effect of Repetative Transcranial Magnetic Stimulation Therapy for Stroke Patients
Official title: The Effect of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: hemiplegia
urinary dysfunction
detrusor overactivity
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effects of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients; A Randomized Study of Double Blind With Sham Control
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Stroke is the second leading cause of death in adults and one of the major causes of long-term disability. Functional limitations that develop in the post-stroke period affect the quality of life and activities of daily living of the patients. The main purpose of stroke rehabilitation is to improve the quality of life of patients in the areas of physical, functional, psychological and social health.

Post-stroke urinary incontinence (PSUI) is a common complication that manifests as involuntary loss of urine. It has been reported that post-stroke urinary incontinence (PSUI) affects 40-60% of patients admitted to the hospital after stroke, up to 25% still have problems when they are discharged from the hospital, and 15% remain incontinence one year later. Recent studies have shown that 79% of stroke survivors develop urinary incontinence.

It has been reported that this complication is also associated with psychological problems such as low self-esteem and anxiety. In addition, the presence of urinary incontinence has been considered a marker of stroke severity and a higher mortality rate than those without urinary incontinence. Therefore, Post-stroke urinary incontinence (PSUI) management is critical and should be the goal of all stroke health professionals.

In recent years, there is a need for more effective approaches on neuroplasticity mechanisms in stroke rehabilitation. Repetitive transcranial magnetic stimulation (rTMS) is an innovative approach applied in this field. With the application of repetitive transcranial magnetic stimulation (rTMS), it is aimed to modulate plasticity and restore the normal activity pattern.

Repetitive transcranial magnetic stimulation (rTMS) is a painless non-invasive technique widely used in clinical routine practice to modulate the neural excitability of the human brain. High frequency rTMS (\>5 Hz) increases neural activity (long term potentiation), while low frequency (1 Hz) rTMS decreases neural activity (long term depression).

Previous studies have shown that detrusor overactivity (DO) constitutes the major urodynamic model of post-stroke urinary incontinence (PSUI).This suggests that the brain, which is the center of incontinence with detrusor overactivity, is a potential target for therapeutic interventions.

Repetitive transcranial magnetic stimulation (rTMS) is a newly developed noninvasive brain stimulation method for the treatment of neurological disorders.When applied to cortical areas corresponding to the pelvic region, it can modulate cortical excitability and induce long-lasting neuroplastic changes.

High-frequency rTMS (\>5 Hz) increases neural activity (long-term potentiation), low-frequency (1 Hz) rTMS decreases neural activity. (long-term depression). Clinical studies have shown that inhibition of bladder activity is possible with low frequency (≤ 1 Hz) rTMS in the primary motor cortex (M1).

Our primary aim is to investigate the effect of low-frequency rTMS treatment on urinary system dysfunctions in the primary motor cortex (M1) in stroke patients.

Eligibility criteria: Inclusion Criteria:

* 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,
* After taking the anamnesis and physical examination, patients who meet the inclusion criteria and whose exclusion criteria were excluded will be included in the study

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline Danish Scale at 15th day and 8th week
timeFrame: up to 8th week
measure: Change from baseline International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at 15th day and 8th week
timeFrame: up to 8th week
Secondary outcomes:
measure: Change from baseline Uroflowmetry and residual urine at 15th day and 8th week
timeFrame: up to 8th week
measure: Change from baseline Overactive Bladder Symptom Score (OABSS) at 15th day and 8th week
timeFrame: up to 8th week
measure: Change from baseline Urinary Incontinence Quality Of Life Scale at 15th day and 8th week
timeFrame: up to 8th week
measure: Change from baseline Barthel İndex at 15th day and 8th week
timeFrame: up to 8th week
measure: Change from baseline Beck's Depression Inventory at 15th day and 8th week
timeFrame: up to 8th week
measure: Change from baseline Quality of Life (Short Form 36 (SF-36)) at 15th day and 8th week [
timeFrame: up to 8th week
Other outcomes:
Locations:
city: Afyon
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
References:
citation: 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.
citation: Nardone 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.