AzTrials
AzTrials

Neurological RehabilitationNCT05554861

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

A study testing Low Frequency rTMS Protocol and Intermittent Theta Burst Stimulation (iTBS) Protocol in people with Neurological Rehabilitation and Stroke, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
Low Frequency rTMS Protocol and Intermittent Theta Burst Stimulation (iTBS) Protocol
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Sep 2022to 13 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Afyonkarahisar Health Sciences University

    Afyonkarahisar, 03200

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Low Frequency rTMS Protocol, Intermittent Theta Burst Stimulation (iTBS) Protocol, Sham rTMS Protocol
Keywords
Repetitive Transcranial Magnetic Stimulation, Hemiplegia, Neurological Rehabilitation
Medical subject headings
Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Frequency rTMS ProtocolDevice

    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) ProtocolDevice

    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 ProtocolDevice

    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).

Study groups in NCT05554861
Study groupRoleWhat they receive
Low Frequency rTMS ProtocolExperimentalIt 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.
Receives: Device: Low Frequency rTMS Protocol
Intermittent Theta Burst Stimulation (iTBS) ProtocolActive comparatorIt 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.
Receives: Device: Intermittent Theta Burst Stimulation (iTBS) Protocol
Sham rTMS ProtocolPlacebo comparatorIt 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.
Receives: Device: Sham rTMS Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Functional Independence Measure (FIM) at 10th day and 6th week

    Functional Independence Measure (FIM) is an approach to functional evaluation, which is widely applied, validated and reliable in Turkish society. FIM analyzes two different aspects of disability, namely motor and cognitive functions. FBO; self-care (42 points), sphincter control (14 points), transfers (21 points), locomotion (14 points), communication (14 points) and social cognition (21 points), which consists of 6 subgroups and evaluates 18 activities. . Each activity is evaluated for functional independence using a 7-point scale.

    Measured: up to 6th week

Secondary outcomes (6)

  1. Change from baseline Quality of Life (Short Form 36 (SF-36)) at 10th day and 6th week

    This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.

    Measured: up to 6th week

  2. Change from baseline Timed Up and Go test (TUG) at 10th day and 6th week

    TUG is a simple test used to assess a person's functional mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk 3 meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. The test will be applied twice with a 10-minute rest break and the best value will be evaluated.

    Measured: up to 6th week

  3. Change from baseline Fugl-Meyer Assessment Lower Extremity (FMA-LE) at 10th day and 6th week

    With FMA-LE, lower extremity motor functions, balances, sensory evaluation, passive range of motion and joint pain can be evaluated. In this scale, for motor evaluation, each item is given a score from 0 to 2 according to performance: 2 points; to be able to complete the details, 1 point; partial execution of details, 0 points; are given in case the details are not achieved. The total score for the lower extremity is 34. In sensory evaluation, there are two parts as superficial and position sense (12 points in total). Passive joint movement and joint pain are evaluated over 40 points under separate headings.

    Measured: up to 6th week

  4. Change from baseline Berg Balance Scale at 10th day and 6th week

    It is a scale that includes 14 instructions and is scored between 0-4 by observing the patient's performance for each instruction. While 0 points are given when the patient cannot do the activity at all, 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating balance disorder, 21-40 points indicating an acceptable balance, 41-56 points indicating good balance. It takes between 10 and 20 minutes to complete the scale.

    Measured: up to 6th week

  5. Change from baseline Ratio of maximum H reflex to maximum M response (Hmax/Mmax Ratio) at 6th week

    For H-reflex measurements, the affected soleus muscle will be stimulated to obtain a compound muscle action potential (CMAP), M-wave, and H-reflex response. The H-reflex has been recognized as a reliable electrophysiological equivalent of the stretch reflex and motor neuron excitability. By electrically stimulating the tibial nerve in the popliteal fossa with 5 mm diameter bipolar surface electrodes, a 1 ms rectangular pulse stimulus will be given every 5 seconds. The recording and reference surface electrodes will be placed on the soleus muscle and Achilles tendon, respectively, and the scanning speed will be set at 5 ms and the sensitivity between 500 μV and 2 mV. The intensity of the stimulation will be gradually increased from below the H-reflex threshold to the maximum M-wave to calculate the Hmax / Mmax ratio (Calculated by dividing the maximum peak-to-peak amplitude of the H-reflex by the M-wave).

    Measured: up to 6th week

  6. Change from baseline Modified Ashworth Scale (MAS) at 10th day and 6th week

    MAS (Modified Ashwort Scale); While the knee is in extension, ankle plantar flexor spasticity will be evaluated and taken as (1=1, 1+=2, 2=3, 3=4, 4=5) for statistical evaluation.

    Measured: up to 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2022
  2. Study start20 Sep 2022
  3. Primary completion20 Sep 2023
  4. Study completion13 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05554861
Sponsor's protocol ID
rTMS22
Status last verified
Nov 2023
First submitted
22 Sep 2022
Last updated
14 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29111342

  • 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.

    PubMed 31901449

  • 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.

    PubMed 29249365

Questions about this trial

What is this clinical trial studying?

A study testing Low Frequency rTMS Protocol and Intermittent Theta Burst Stimulation (iTBS) Protocol in people with Neurological Rehabilitation and Stroke, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Functional Independence Measure (FIM) at 10th day and 6th week (time frame: up to 6th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05554861, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in