Hemiplegia Following Ischemic StrokeNCT06696547
The Effects of Cerebellar Intermittent Theta Burst Stimulation on Gait, Balance, and Disease Anxiety In Stroke Patients
A study testing Transcranial Magnetic Stimulation in people with Hemiplegia Following Ischemic Stroke, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Our study was designed to investigate the effect of cerebellar intermittent theta burst stimulation (iTBS) combined with conventional rehabilitation methods on balance, gait and disease anxiety in patients with ischemic stroke who have residual balance and gait disturbance, using clinical measurement parameters. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiplegia Following Ischemic Stroke
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 30 Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ischemic stroke,
- Duration between 2 months to 2 years post-stroke,
- Hemiparesis and residual gait and balance disorders related to the lesion in the MCA area (Berg Balance Scale score < 40),
- Lower extremity Brunnstrom value of at least 3 ,
- Mini Mental State Examination ≥ 24,
- Between 18-80 years old
Who cannot join
- History of seizures,
- Severe general impairmet or concomittant disease,
- Using benzodiazepines, baclofen or antidepressants,
- Having a cardiac pacemaker, cochlear implant, metallic implants in the brain or skull,
- Pregnancy,
- Under 18 or over 80 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cerebellar Intermittent Theta Burst Stimulation Combined With Conventional Rehabilitation Methods on Gait, Balance, and Disease Anxiety in Patients With Ischemic Stroke
Our study was designed to investigate the effect of cerebellar intermittent theta burst stimulation (iTBS) combined with conventional rehabilitation methods on balance, gait and disease anxiety in patients with ischemic stroke who have residual balance and gait disturbance, using clinical measurement parameters.
Read the detailed description
Loss of balance and gait functions, which are neurological impairments related to stroke, are among the common functional losses depending on the affected brain region. Reduced independence in daily living activities can lead to increased anxiety during ambulation, risk of falling and fear of falling. Studies have shown that applying theta burst stimulation (TBS) to the cerebellum has long-term effects on the excitability of the cerebello-thalamo-cortical pathways and stimulates synaptic plasticity through various mechanisms. In the literature, there are studies examining the effects of cerebellar iTBS on balance and walking functions in stroke patients, but the number of studies are quite limited.
This study was planned as a prospective, randomized, sham-controlled clinical study. According to the statistical analysis 30 patients who were registered at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital between February 2022 and April 2023 and met the study criteria were included. The patients were divided into two groups: active (n=15) and sham (n=15). Each group received 30 sessions of either active or sham cerebellar iTBS (CRB-iTBS). Additionally, patients received therapeutic interventions from a physiotherapist, including range of motion exercises, stretching, neurophysiological exercises, balance-coordination training, active-assistive mobilization, and exercises for daily living.
The CRB-iTBS treatment targeted the cerebellum on the opposite side to the cerebral lesions, administered in a total of 30 sessions, twice a day with a 5-minute interval between sessions, over a period of 3 weeks. Each stimulation session consisted of 3-burst pulses at a frequency of 50 Hz, with a 10-second repetitive cycle of 2-second stimulations lasting a total of 190 seconds, delivering 600 pulses per session. Each day, a total of 1200 pulses were administered over two sessions, spaced 5 minutes apart. Patients in the sham CRB-iTBS group received the same protocol with a sham coil that visually resembled the active coil.
Clinical evaluations were conducted three times for each patient: Baseline (before treatment), 3rd week (at the and of treatment), and 6th week.
- Conditions
- Hemiplegia Following Ischemic Stroke
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
- Keywords
- Stroke, Transcranial Magnetic Stimulation, Gait, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil
Transcranial Magnetic Stimulation ShamDevice
Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil
| Study group | Role | What they receive |
|---|---|---|
| Active CRB-iTBS | Active comparator | Patients received a total of 30 sessions active CRB-iTBS targeting contralesional lateral cerebellum, 5 days a week for 3 weeks. The cerebellar region to be targeted, on the opposite side of the cerebral lesion, was determined by measuring 3 cm lateral and 1 cm inferior of the inion, which is the anatomical prominence on the occipital bone (3L1I). Stimulation intensity was set at 80% of the active motor threshold (AMT). AMT was defined as the lowest intensity required for a motor-evoked potentials (MEP) above 200 µV in at least 50% of 10 trials when the patient was contracting targeted muscle 10% on the maximum voluntary contraction. Stimulation was administered as 3-burst pulses at a frequency of 50 Hz, with 2-second stimulation repeated every 10 seconds period. This continued for a total duration of 190 seconds, delivering 600 pulses. Each CRB-iTBS session was performed in 2 sessions before daily rehabilitation programs. Thus, 1200 pulses were applied per day. Receives: Device: Transcranial Magnetic Stimulation |
| Sham CRB-iTBS | Sham comparator | Patients received a total of 30 sessions sham CRB-iTBS targeting contralesional lateral cerebellum, 5 days a week for 3 weeks. The cerebellar region to be targeted, on the opposite side of the cerebral lesion, was determined by measuring 3 cm lateral and 1 cm inferior of the inion, which is the anatomical prominence on the occipital bone (3L1I). However, sham coil was used for stimulation. Therefore, no real stimulation was applied to the patients. Instead, a sensation mimicking real stimulation was created through the sham coil, with sounds and sensations on the scalp as if stimulation were occurring. Each sham CRB-iTBS session was performed in 2 sessions before daily rehabilitation programs. Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
This is a scale used to evaluate patients' balance during 14 different activities. These activities include: sitting to standig, standing unsupported, sitting unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing with feet together, reaching forward while standing, picking up an object from the floor, looking back over the shoulder on both the right and left sides, turning 360 degrees, placing a foot on a stool, standing in a toe-heel position, and standing on one foot. The total score after performing the test determines the predicted risk of falls. The minimum score on the test is 0, and the maximum score is 56. Scores are classified as follows: 0-20 indicates a high risk of falling, 21-40 indicates a moderate risk of falling, and 41-56 indicates a low risk of falling.
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Gait Analysis- Step Length
The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step length (cm).
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Gait Analysis- Step Width
The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step width (cm).
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Gait Analysis- Walking Speed
The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included walking speed (km/h).
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Secondary outcomes (4)
International Falls Efficacy Scale (FES-I)
Patients are evaluated for their level of concern about the risk of falling during 16 different activities. A score of 1 reflects no concern, while a score of 4 reflects a high level of concern. Total scores range from 16 to 64, with higher scores indicating greater anxiety about falling and lower self-confidence during activities.
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Barthel Index for Activities of Daily Living (BI)
The Barthel Index (BI) was used to assess physical independence in daily activities on ten-item scale. These items are: feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfer (bed to chair and back), mobility (on level surfaces). Score of 0 indicating complete dependence and a score of 100 indicating complete independence.
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Stroke Specific Quality of Life Scale (SS-QOL)
The Stroke-Specific Quality of Life Scale (SS-QOL) assesses the functionality and quality of life in stroke patients through 49 questions across 12 categories. These categories include: thinking, upper extremity functions, vision, work/productivity, social roles, self-care, personality, mood, mobility, language, family roles, and energy. Scoring is done on a scale from 1 to 5, with a total score ranging from 49 to 245. A score of 49 indicates very low quality of life, while a score of 245 indicates high quality of life.
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) consists of 14 questions, which are to be answered based on the patient's experience over the past few days while hospitalized. Seven of the questions assess depression, and seven assess anxiety levels. Separate scoring is done for anxiety and depression. The score may range between 0 and 21 per subscale. Higher scores indicate higher levels of anxiety and depression.
Measured: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start28 Feb 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia Following Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miray Karamehmetoğlu, Ankara City Hospital Bilkent
- Investigators
- Filiz Acar Sivas, Prof, MD, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696547
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-MK-01
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cerebellar Intermittent Theta Burst Stimulation Combined With Conventional Rehabilitation Methods on Gait, Balance, and Disease Anxiety in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06696547
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-MK-01
- Conditions
- Hemiplegia Following Ischemic Stroke
- Keywords
- Stroke, Transcranial Magnetic Stimulation, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study was designed to investigate the effect of cerebellar intermittent theta burst stimulation (iTBS) combined with conventional rehabilitation methods on balance, gait and disease anxiety in patients with ischemic stroke who have residual balance and gait disturbance, using clinical measurement parameters.
Detailed description
Loss of balance and gait functions, which are neurological impairments related to stroke, are among the common functional losses depending on the affected brain region. Reduced independence in daily living activities can lead to increased anxiety during ambulation, risk of falling and fear of falling. Studies have shown that applying theta burst stimulation (TBS) to the cerebellum has long-term effects on the excitability of the cerebello-thalamo-cortical pathways and stimulates synaptic plasticity through various mechanisms. In the literature, there are studies examining the effects of cerebellar iTBS on balance and walking functions in stroke patients, but the number of studies are quite limited.
This study was planned as a prospective, randomized, sham-controlled clinical study. According to the statistical analysis 30 patients who were registered at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital between February 2022 and April 2023 and met the study criteria were included. The patients were divided into two groups: active (n=15) and sham (n=15). Each group received 30 sessions of either active or sham cerebellar iTBS (CRB-iTBS). Additionally, patients received therapeutic interventions from a physiotherapist, including range of motion exercises, stretching, neurophysiological exercises, balance-coordination training, active-assistive mobilization, and exercises for daily living.
The CRB-iTBS treatment targeted the cerebellum on the opposite side to the cerebral lesions, administered in a total of 30 sessions, twice a day with a 5-minute interval between sessions, over a period of 3 weeks. Each stimulation session consisted of 3-burst pulses at a frequency of 50 Hz, with a 10-second repetitive cycle of 2-second stimulations lasting a total of 190 seconds, delivering 600 pulses per session. Each day, a total of 1200 pulses were administered over two sessions, spaced 5 minutes apart. Patients in the sham CRB-iTBS group received the same protocol with a sham coil that visually resembled the active coil.
Clinical evaluations were conducted three times for each patient: Baseline (before treatment), 3rd week (at the and of treatment), and 6th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CRB-iTBS | Active comparator | Device: Transcranial Magnetic StimulationPatients received a total of 30 sessions active CRB-iTBS targeting contralesional lateral cerebellum, 5 days a week for 3 weeks. The cerebellar region to be targeted, on the opposite side of the cerebral lesion, was determined by measuring 3 cm lateral and 1 cm inferior of the inion, which is the anatomical prominence on the occipital bone (3L1I). Stimulation intensity was set at 80% of the active motor threshold (AMT). AMT was defined as the lowest intensity required for a motor-evoked potentials (MEP) above 200 µV in at least 50% of 10 trials when the patient was contracting targeted muscle 10% on the maximum voluntary contraction. Stimulation was administered as 3-burst pulses at a frequency of 50 Hz, with 2-second stimulation repeated every 10 seconds period. This continued for a total duration of 190 seconds, delivering 600 pulses. Each CRB-iTBS session was performed in 2 sessions before daily rehabilitation programs. Thus, 1200 pulses were applied per day. |
| Sham CRB-iTBS | Sham comparator | Device: Transcranial Magnetic Stimulation ShamPatients received a total of 30 sessions sham CRB-iTBS targeting contralesional lateral cerebellum, 5 days a week for 3 weeks. The cerebellar region to be targeted, on the opposite side of the cerebral lesion, was determined by measuring 3 cm lateral and 1 cm inferior of the inion, which is the anatomical prominence on the occipital bone (3L1I). However, sham coil was used for stimulation. Therefore, no real stimulation was applied to the patients. Instead, a sensation mimicking real stimulation was created through the sham coil, with sounds and sensations on the scalp as if stimulation were occurring. Each sham CRB-iTBS session was performed in 2 sessions before daily rehabilitation programs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First ischemic stroke,
- Duration between 2 months to 2 years post-stroke,
- Hemiparesis and residual gait and balance disorders related to the lesion in the MCA area (Berg Balance Scale score < 40),
- Lower extremity Brunnstrom value of at least 3 ,
- Mini Mental State Examination ≥ 24,
Key exclusion criteria (6 listed)
- History of seizures,
- Severe general impairmet or concomittant disease,
- Using benzodiazepines, baclofen or antidepressants,
- Having a cardiac pacemaker, cochlear implant, metallic implants in the brain or skull,
- Pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationMagstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil | Device | Active CRB-iTBS |
| Transcranial Magnetic Stimulation ShamMagstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil | Device | Sham CRB-iTBS |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
This is a scale used to evaluate patients' balance during 14 different activities. These activities include: sitting to standig, standing unsupported, sitting unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing with feet together, reaching forward while standing, picking up an object from the floor, looking back over the shoulder on both the right and left sides, turning 360 degrees, placing a foot on a stool, standing in a toe-heel position, and standing on one foot. The total score after performing the test determines the predicted risk of falls. The minimum score on the test is 0, and the maximum score is 56. Scores are classified as follows: 0-20 indicates a high risk of falling, 21-40 indicates a moderate risk of falling, and 41-56 indicates a low risk of falling.
Gait Analysis- Step Length
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step length (cm).
Gait Analysis- Step Width
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included step width (cm).
Gait Analysis- Walking Speed
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
The Zebris FDM Type 3 (Zebris Medical GmbH, Germany) device was used to record spatiotemporal data during walking. This system consists of a 3-meter straight platform, with two 1-meter maneuvering platforms at the start and end. It is equipped with sensors and computer software for data analysis. The data collected in the study included walking speed (km/h).
4 secondary outcomes
International Falls Efficacy Scale (FES-I)
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Barthel Index for Activities of Daily Living (BI)
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Acar Sivas, Prof, MD study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Hemiplegia Following Ischemic Stroke, run by Ankara City Hospital Bilkent 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 6 inclusion and 6 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 20 Nov 2024. 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?
Berg Balance Scale (BBS) (time frame: Baseline (before treatment), 3rd week (at the end of treatment), 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.