The Effect of Repetative Transcranial Magnetic Stimulation Therapy for Stroke Patients

NCT ID: NCT05738863

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2024-06-01

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.

Conditions

Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Low Frequency rTMS Protocol

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.

Group Type: EXPERIMENTAL

Low Frequency rTMS Protocol

Intervention Type: DEVICE

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.

Sham rTMS Protocol

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.

Group Type: PLACEBO_COMPARATOR

Sham rTMS Protocol

Intervention Type: DEVICE

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.

Interventions

Low Frequency rTMS Protocol

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.

Intervention Type: DEVICE

Sham rTMS Protocol

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.

Intervention Type: DEVICE

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,

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Ayşenur Beysel

Research Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ayşenur Beysel, MD

Role: CONTACT

aysenur.beysel94@gmail.com

5544808858 ext. +90

Hilal Yeşil, MD

Role: CONTACT

dradanur@yahoo.com

5054423141 ext. +90

Facility Contacts

Ayşenur Beysel, MD

Role: primary

aysenur.beysel94@gmail.com

5544808858 ext. +90

Hilal Yeşil, MD

Role: backup

dradanur@yahoo.com

5054423141 ext. +90

References

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.

Reference Type: RESULT

PMID: 35964135 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31541980 (View on PubMed)

Other Identifiers

586

Identifier Type: -

Identifier Source: org_study_id