Clinical trial NCT05554861: Effects of Repetitive Transcranial Magnetic Stimulation Therapy on Lower Extremity Motor Development in Stroke Patients
Official title: Effects of Repetitive Transcranial Magnetic Stimulation Therapy on Quality of Life, Mobility and Lower Extremity Motor Development in Stroke Patients: A Randomized Study of Double Blind With Sham Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Rehabilitation
Stroke
Lower Extremity Problem
Quality of Life
Keywords: Repetitive Transcranial Magnetic Stimulation
Hemiplegia
Neurological Rehabilitation
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of rTMS applications at different current frequencies (low frequency / intermittent (intermittent) theta burst (iTBS)) in stroke patients on lower extremity motor development, physical function and quality of life, and to compare the effectiveness of these modalities.

Detailed description: Stroke is the second leading cause of mortality in adults and is the main cause 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 increase the quality of life by adopting multidimensional approaches that aim to reach the maximum level of independence in the physical, functional, psychological and social health areas of the patients.

Thanks to the neuroplasticity mechanisms that develop in the brain in the post-stroke period, it is aimed to activate the cortical areas directly affected by the stroke by creating new connections in the neuronal networks. With increased activation, clinical motor recovery occurs. Conventional therapy methods are an important tool for motor recovery, however, the effects of treatment outcomes are often limited, especially when applied to chronic patients. 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). Theta burst excitation (TBS), on the other hand, is a undulating form.

Several systematic reviews have evaluated the efficacy and safety of rTMS for various functional and psychological outcomes in people after stroke. In the literature, rTMS is used in patients with acute, subacute and chronic stroke to improve upper and lower extremity functions, as well as in the rehabilitation of dysphagia and aphasia.

The aim of our study is to investigate the effects of rTMS applications at different current frequencies (low frequency / intermittent (intermittent) theta burst (iTBS)) on patients with stroke on lower extremity motor development, physical function and quality of life, and to compare the effectiveness of these modalities.

Eligibility criteria: Inclusion Criteria:

* Having lower extremity Brunnstrom motor stage in the 3-5 range,
* Having had a stroke at least six months ago,
* Being able to walk 5 meters independently with or without an assistive device,
* Ability to follow two-stage verbal commands,
* To agree to participate in the study voluntarily and regularly,
* Being medically stable (without a history of myocardial infarction, without musculoskeletal problems)
* Patients with a mini mental test of 24 and above will be accepted into our study.

Exclusion Criteria:

* Severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and a significant comorbid disease such as uncontrolled hypertension,
* Cognitive dysfunction,
* Visual impairment,
* Hearing problem,
* Malignancy and active infection,
* Skin infection in the rTMS application area,
* Open wound,
* Inflammatory disease,
* Epilepsy,
* Brain lesion or a history of drug use that will affect the seizure threshold,
* Patients with increased intracranial pressure or uncontrolled migraine will not be included.

Primary outcomes:
measure: Change from baseline Functional Independence Measure (FIM) at 10th day and 6th week
timeFrame: up to 6th week
Secondary outcomes:
measure: Change from baseline Quality of Life (Short Form 36 (SF-36)) at 10th day and 6th week
timeFrame: up to 6th week
measure: Change from baseline Timed Up and Go test (TUG) at 10th day and 6th week
timeFrame: up to 6th week
measure: Change from baseline Fugl-Meyer Assessment Lower Extremity (FMA-LE) at 10th day and 6th week
timeFrame: up to 6th week
measure: Change from baseline Berg Balance Scale at 10th day and 6th week
timeFrame: up to 6th week
measure: Change from baseline Ratio of maximum H reflex to maximum M response (Hmax/Mmax Ratio) at 6th week
timeFrame: up to 6th week
measure: Change from baseline Modified Ashworth Scale (MAS) at 10th day and 6th week
timeFrame: up to 6th week
Other outcomes:
Locations:
city: Afyonkarahi̇sar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ali Izzet AKÇİN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. The Use of Repetitive Transcranial Magnetic Stimulation for Stroke Rehabilitation: A Systematic Review. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):1-31. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.008. Epub 2017 Oct 27.
citation: Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
citation: Watanabe K, Kudo Y, Sugawara E, Nakamizo T, Amari K, Takahashi K, Tanaka O, Endo M, Hayakawa Y, Johkura K. Comparative study of ipsilesional and contralesional repetitive transcranial magnetic stimulations for acute infarction. J Neurol Sci. 2018 Jan 15;384:10-14. doi: 10.1016/j.jns.2017.11.001. Epub 2017 Nov 9.