Effects of Repetitive Transcranial Magnetic Stimulation Therapy on Lower Extremity Motor Development in Stroke Patients

NCT ID: NCT05554861

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2023-11-13

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.

Conditions

Neurological Rehabilitation; Stroke; Lower Extremity Problem; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Frequency rTMS Protocol

It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex foot area in the non-lesional hemisphere, 5 days a week for 2 weeks, for a total of 10 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 foot area in the non-lesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

After the daily rTMS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Intermittent Theta Burst Stimulation (iTBS) Protocol

It was planned to apply 50 Hz high-frequency stimulation protocol to the primary motor cortex foot area in the ipsilesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

Group Type: ACTIVE_COMPARATOR

Intermittent Theta Burst Stimulation (iTBS) Protocol

Intervention Type: DEVICE

It was planned to apply 50 Hz high-frequency stimulation protocol to the primary motor cortex foot area in the ipsilesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

After the daily rTBS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Sham rTMS Protocol

It was planned to apply daily sham rTMS to the motor extremity area of the primary motor cortex along a 10 cm thick wood for 10 sessions.

Group Type: PLACEBO_COMPARATOR

Sham rTMS Protocol

Intervention Type: DEVICE

It was planned to apply daily sham rTMS to the motor extremity area of the primary motor cortex along a 10 cm thick wood for 10 sessions.

After the daily sham rTMS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Interventions

Low Frequency rTMS Protocol

It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex foot area in the non-lesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

After the daily rTMS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Intervention Type: DEVICE

Intermittent Theta Burst Stimulation (iTBS) Protocol

It was planned to apply 50 Hz high-frequency stimulation protocol to the primary motor cortex foot area in the ipsilesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

After the daily rTBS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Intervention Type: DEVICE

Sham rTMS Protocol

It was planned to apply daily sham rTMS to the motor extremity area of the primary motor cortex along a 10 cm thick wood for 10 sessions.

After the daily sham rTMS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Nuran Eyvaz

Asistant Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuran EYVAZ, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Ali Izzet AKÇİN, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 29111342 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31901449 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29249365 (View on PubMed)

Other Identifiers

rTMS22

Identifier Type: -

Identifier Source: org_study_id