Stroke, IschemicNCT05646134
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients
A study testing Repetitive Transcranial Magnetic Stimulation in people with Stroke, Ischemic, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
This clinical trial aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it seeks to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jun 2021to 1 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke of the middle cerebral artery, confirmed by instrumental tests (CT, MRI).
- Acute hemiplegia/hemiparesis, hand motor deficit, muscle strength ≤ 4 points (as assessed by the Lovett scale).
- Time after the stroke before inclusion in the study is no more than 1 month.
- No severe deficit in cognitive functions.
Who cannot join
- Patients with implanted ferromagnetic or other metal devices sensitive to a magnetic field in the head or neck area; cochlear implants; implanted neurostimulators, pacemakers, or drug delivery pumps.
- Complete aphasia or severe cognitive impairment.
- Taking tricyclic antidepressants, neuroleptics, or benzodiazepines.
- Previous skull fractures or other head injuries with loss of consciousness.
- History of epilepsy or seizures.
- Spasticity of the upper limb (Ashworth scale >2 b.).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, 44307
Judita Tuzaitė, +370 32 72 01, rektoratas@lsmuni.lt
About this study
This clinical trial aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it seeks to answer are:
- Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients.
- Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation.
Researchers will compare sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.
Read the detailed description
The aim of this clinical trial is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it aims to answer are:
- Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients.
- Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation by conducting Fugl Meyer Assessment for Upper Extremity, Box and Blog test, nine-hole peg test, and by measuring hand grip strength.
Researchers will compare experimental groups with sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.
- Conditions
- Stroke, Ischemic
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- Stroke, Stroke rehabilitation, Repetitive transcranial magnetic stimulation
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability.
Sham Transcranial Magnetic StimulationDevice
During Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive
| Study group | Role | What they receive |
|---|---|---|
| Low Frequency Experimental Group | Experimental | Participants in this Arm will receive 10 sessions of Low Frequency (1 Hz) rTMS Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| High Frequency Experimental Group | Experimental | Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Sham Stimulation Control Group | Sham comparator | Participants in this Arm will receive 10 sessions of Sham rTMS Receives: Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of upper limb motor score in Fugl-Meyer Assessment
Fugl-Meyer test for Upper Extremity will be performed before and one month after 10 rTMS sessions. The minimum value of the Fugl-Meyer Assessment is 0 whereas the maximum value is 66 points. The higher the score the better the motor function of the upper extremity.
Measured: 7 weeks
Change of Nine Hole Peg Test (9HPT) score
Nine Hole Peg Test (9HPT) will be performed before and one month after 10 rTMS sessions for measuring finger dexterity. During 9HPT a patient takes the pegs from a container, one by one, and places them into the holes on the board, as quickly as possible, using only the hand. The faster a patient finishes the test the better finger dexterity (measured by seconds).
Measured: 7 weeks
Change of box and block test (BBT) score
Box and block test (BBT) will be performed before and one month after 10 rTMS sessions for measuring unilateral gross manual dexterity. During BBT a patient moves, one by one, the maximum number of blocks from one compartment of a box to another within 60 seconds. The more blocks are moved to another compartment the better the manual dexterity of the upper extremity.
Measured: 7 weeks
Change of hand grip strength
Hand grip strength will be measured in kilograms using a dynamometer before and one month after 10 rTMS sessions. The higher the score the stronger the forearm muscles.
Measured: 7 weeks
Secondary outcomes (1)
Change of Functional Independence Measure (FIM) test score.
Functional Independence Measure (FIM) will be performed before and one month after 10 rTMS sessions. The minimum value of FIM is 18 whereas the maximum value is 126. The higher the score the better functional independence.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jun 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raimondas Savickas, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646134
- Sponsor's protocol ID
- rTMS_1
- Status last verified
- Dec 2022
- First submitted
- 25 Oct 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT05646134
- Acronym / sponsor ID
- rTMS_1
- Conditions
- Stroke, Ischemic
- Keywords
- Stroke, Stroke rehabilitation, Repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Dec 2022 (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.
This clinical trial aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it seeks to answer are:
- Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients.
- Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation.
Researchers will compare sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.
Detailed description
The aim of this clinical trial is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it aims to answer are:
- Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients.
- Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation by conducting Fugl Meyer Assessment for Upper Extremity, Box and Blog test, nine-hole peg test, and by measuring hand grip strength.
Researchers will compare experimental groups with sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Frequency Experimental Group | Experimental | Device: Repetitive Transcranial Magnetic StimulationParticipants in this Arm will receive 10 sessions of Low Frequency (1 Hz) rTMS Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS |
| High Frequency Experimental Group | Experimental | Device: Repetitive Transcranial Magnetic StimulationParticipants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS |
| Sham Stimulation Control Group | Sham comparator | Device: Sham Transcranial Magnetic StimulationParticipants in this Arm will receive 10 sessions of Sham rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke of the middle cerebral artery, confirmed by instrumental tests (CT, MRI).
- Acute hemiplegia/hemiparesis, hand motor deficit, muscle strength ≤ 4 points (as assessed by the Lovett scale).
- Time after the stroke before inclusion in the study is no more than 1 month.
- No severe deficit in cognitive functions.
Key exclusion criteria (7 listed)
- Patients with implanted ferromagnetic or other metal devices sensitive to a magnetic field in the head or neck area; cochlear implants; implanted neurostimulators, pacemakers, or drug delivery pumps.
- Complete aphasia or severe cognitive impairment.
- Taking tricyclic antidepressants, neuroleptics, or benzodiazepines.
- Previous skull fractures or other head injuries with loss of consciousness.
- History of epilepsy or seizures.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationRepetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability. | Device | High Frequency Experimental Group, Low Frequency Experimental Group |
| Sham Transcranial Magnetic StimulationDuring Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive | Device | Sham Stimulation Control Group |
Primary outcome
Change of upper limb motor score in Fugl-Meyer Assessment
Time frame: 7 weeks
Fugl-Meyer test for Upper Extremity will be performed before and one month after 10 rTMS sessions. The minimum value of the Fugl-Meyer Assessment is 0 whereas the maximum value is 66 points. The higher the score the better the motor function of the upper extremity.
Change of Nine Hole Peg Test (9HPT) score
Time frame: 7 weeks
Nine Hole Peg Test (9HPT) will be performed before and one month after 10 rTMS sessions for measuring finger dexterity. During 9HPT a patient takes the pegs from a container, one by one, and places them into the holes on the board, as quickly as possible, using only the hand. The faster a patient finishes the test the better finger dexterity (measured by seconds).
Change of box and block test (BBT) score
Time frame: 7 weeks
Box and block test (BBT) will be performed before and one month after 10 rTMS sessions for measuring unilateral gross manual dexterity. During BBT a patient moves, one by one, the maximum number of blocks from one compartment of a box to another within 60 seconds. The more blocks are moved to another compartment the better the manual dexterity of the upper extremity.
Change of hand grip strength
Time frame: 7 weeks
Hand grip strength will be measured in kilograms using a dynamometer before and one month after 10 rTMS sessions. The higher the score the stronger the forearm muscles.
1 secondary outcome
Change of Functional Independence Measure (FIM) test score.
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Stroke, Ischemic, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Petrusevičienė, MD (+37064410732, lciginskaite@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of upper limb motor score in Fugl-Meyer Assessment (time frame: 7 weeks). 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 12 Dec 2022.