Chronic StrokeNCT05134324
The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke
A study testing active rTMS and active tDCS in people with Chronic Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- active rTMS and active tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2021to 25 May 2022
- 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 with a disease interval of 6 months to 2 years
- aged based 18 years
- first stroke
- Mini mental test score ≥ 22
- upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
- Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC
Who cannot join
- hemorrhagic stroke
- history of epilepsy
- a cardiac pacemaker
- pregnancy
- Fugl Meyer upper extremity assessment score ≥44
- history of previous stroke or ischemic attack
Show all 12Show fewer
- neurological diseases other than stroke
- metallic implant in brain or scalp (including cochlear implant)
- previous brain surgery
- orthopedic disease that prevents upper extremity movements
- diagnosis of malignancy
- receiving robotic /TMS/tDCS treatments in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke
The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery
Read the detailed description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.
- Conditions
- Chronic Stroke
- Being tested
- active rTMS, sham rTMS, active tDCS, sham tDCS
- Keywords
- stroke, rTMS, tDCS, robotic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSOther
Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper extremity just after each active TMS sessions.
sham rTMSOther
Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for upper extremity just after each sham TMS sessions.
active tDCSOther
Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper extremity just after each active tDCS sessions.
sham tDCSOther
Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for upper extremity just after each sham tDCS sessions
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for upper extremity just after each active TMS sessions Receives: Other: active rTMS |
| sham rTMS | Sham comparator | Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for upper extremity just after each sham TMS sessions Receives: Other: sham rTMS |
| active tDCS | Experimental | Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for upper extremity just after each active tDCS sessions Receives: Other: active tDCS |
| sham tDCS | Sham comparator | Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions Receives: Other: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Motor Function Scale
Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
Measured: initial, 3th week 9th week changes
Secondary outcomes (6)
Motor Activity Log-28
Scale measures frequency of use and functionality level of the affected upper limb during daily activities (min-max: 0-5 points). Higher values represent a better outcome.
Measured: initial, 3th week 9th week changes
Barthel Index
Scale measures performance in activities of daily living. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence.
Measured: initial, 3th week 9th week changes
Stroke Impact Scale version 3.0
Scale has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better Scores for each domain range from 0 to 100, and higher scores indicate a better. The scale also includes a question (item 50) to assess the patient's global perception of recovery. The respondent is asked to rate his or her percentage of recovery on a visual analog scale of 0 to 100, with 0 meaning no recovery and 100 meaning full recovery.
Measured: initial, 3th week 9th week changes
Box and Block Test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome.
Measured: initial, 3th week 9th week changes
Modified Ashworth Scale
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome
Measured: initial, 3th week 9th week changes
The amplitude of motor evoked potentials (MEPs)
The amplitude of MEP is a common yet highly variable measure of corticospinal excitability.
Measured: initial, 3th week 9th week changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start25 May 2021
- Primary completion25 Feb 2022 (estimated)
- Study completion25 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Esra Celik Karbancioglu, MD, Study director, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134324
- Sponsor's protocol ID
- 22
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05134324
- Acronym / sponsor ID
- 22
- Conditions
- Chronic Stroke
- Keywords
- stroke, rTMS, tDCS, robotic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 Feb 2022 (estimated)
- Study completion
- 25 May 2022 (estimated)
- First posted
- 24 Nov 2021 (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.
The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery
Detailed description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Other: active rTMSParticipants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for upper extremity just after each active TMS sessions |
| sham rTMS | Sham comparator | Other: sham rTMSParticipants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for upper extremity just after each sham TMS sessions |
| active tDCS | Experimental | Other: active tDCSParticipants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for upper extremity just after each active tDCS sessions |
| sham tDCS | Sham comparator | Other: sham tDCSParticipants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ischemic stroke with a disease interval of 6 months to 2 years
- aged based 18 years
- first stroke
- Mini mental test score ≥ 22
- upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
Key exclusion criteria (12 listed)
- hemorrhagic stroke
- history of epilepsy
- a cardiac pacemaker
- pregnancy
- Fugl Meyer upper extremity assessment score ≥44
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 |
|---|---|---|
| active rTMSParticipants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper extremity just after each active TMS sessions. | Other | active rTMS |
| sham rTMSParticipants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for upper extremity just after each sham TMS sessions. | Other | sham rTMS |
| active tDCSParticipants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper extremity just after each active tDCS sessions. | Other | active tDCS |
| sham tDCSParticipants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for upper extremity just after each sham tDCS sessions | Other | sham tDCS |
Primary outcome
Upper Extremity Fugl-Meyer Motor Function Scale
Time frame: initial, 3th week 9th week changes
Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
6 secondary outcomes
Motor Activity Log-28
Time frame: initial, 3th week 9th week changes
Barthel Index
Time frame: initial, 3th week 9th week changes
Stroke Impact Scale version 3.0
Time frame: initial, 3th week 9th week changes
Box and Block Test
Time frame: initial, 3th week 9th week changes
Modified Ashworth Scale
Time frame: initial, 3th week 9th week changes
The amplitude of motor evoked potentials (MEPs)
Time frame: initial, 3th week 9th week changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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.
Esra Celik Karbancioglu, MD study director
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS and active tDCS in people with Chronic Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 12 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 24 Nov 2021. 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?
Results are not available in the source record.
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?
Upper Extremity Fugl-Meyer Motor Function Scale (time frame: initial, 3th week 9th week changes). 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 24 Nov 2021.