StrokePhase 3NCT02542982
tDCS and Motor Training and Motor Deficit After Stroke
A Phase 3 study testing tDCS (Endomed 482; Enraf-Nonius B.V.) in people with Stroke, run by Military Medical Academy, Belgrade, Serbia at 1 site in Serbia.
Trial summary
This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS (Endomed 482; Enraf-Nonius B.V.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSerbia
- Study dates
- Apr 2013to Mar 2015
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans
- stroke duration > 12 months
- severe hand deficit at stroke onset (Medical Research Council grade <2) and
- subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts),
- spasticity between 0-2 assessed on the Modified Ashworth Scale
Who cannot join
- any clinically significant or unstable medical disorder,
- diagnosis od major depression,
- diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination < 24).
- any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic of Neurology, Military Medical Academy, Belgrade
Belgrade, 11000
About this study
Official title: Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke
This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.
Read the detailed description
A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence.
This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients.
Patients with chronic hand motor deficits after stroke (> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS.
Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).
- Conditions
- Stroke
- Being tested
- tDCS (Endomed 482; Enraf-Nonius B.V.)
- Keywords
- tDCS, motor recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS (Endomed 482; Enraf-Nonius B.V.)Device
non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Group of patients on active treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by 20 minutes of 2 mA anodal tDCS over the ipsilesional motor cortex. Receives: Device: tDCS (Endomed 482; Enraf-Nonius B.V.) |
| Sham comparator | Sham comparator | Group of patients on sham treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by sham tDCS over the ipsilesional motor cortex. Receives: Device: tDCS (Endomed 482; Enraf-Nonius B.V.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen Taylor Test of Hand Function
changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately
Measured: one day, two weeks and one month
Secondary outcomes (2)
hand grip force
changes of baseline maximum grip force of the hand measured by whole-hand dynamometer
Measured: two weeks and one month
upper limb Fugl-Meyer assessment of Motor Recovery after Stroke
changes of initial score from domain of motor functions for upper limb
Measured: one day, two weeks and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Medical Academy, Belgrade, Serbia
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Centre of Serbia
- Responsible party
- Principal investigator, Tihomir Ilic, Military Medical Academy, Belgrade, Serbia
- Investigators
- Tihomir V Ilic, MD, PhD, Principal investigator, Military Medical Academy, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542982
- Sponsor's protocol ID
- MFVMA/12/13-15
- Status last verified
- Sep 2015
- First submitted
- 21 Mar 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke
- ClinicalTrials.gov ID
- NCT02542982
- Acronym / sponsor ID
- MFVMA/12/13-15
- Conditions
- Stroke
- Keywords
- tDCS, motor recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Military Medical Academy, Belgrade, SerbiaUniversity, hospital or other
- Collaborators
- Clinical Centre of Serbia
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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 study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.
Detailed description
A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence.
This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients.
Patients with chronic hand motor deficits after stroke (> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS.
Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: tDCS (Endomed 482; Enraf-Nonius B.V.)Group of patients on active treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by 20 minutes of 2 mA anodal tDCS over the ipsilesional motor cortex. |
| Sham comparator | Sham comparator | Device: tDCS (Endomed 482; Enraf-Nonius B.V.)Group of patients on sham treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by sham tDCS over the ipsilesional motor cortex. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans
- stroke duration > 12 months
- severe hand deficit at stroke onset (Medical Research Council grade <2) and
- subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts),
- spasticity between 0-2 assessed on the Modified Ashworth Scale
Key exclusion criteria (4 listed)
- any clinically significant or unstable medical disorder,
- diagnosis od major depression,
- diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination < 24).
- any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants
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 |
|---|---|---|
| tDCS (Endomed 482; Enraf-Nonius B.V.)non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered | Device | Active treatment, Sham comparator |
Primary outcome
Jebsen Taylor Test of Hand Function
Time frame: one day, two weeks and one month
changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately
2 secondary outcomes
hand grip force
Time frame: two weeks and one month
upper limb Fugl-Meyer assessment of Motor Recovery after Stroke
Time frame: one day, two weeks and one month
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 7 Sep 2015.
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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.
Tihomir V Ilic, MD, PhD principal investigator
Military Medical Academy, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tDCS (Endomed 482; Enraf-Nonius B.V.) in people with Stroke, run by Military Medical Academy, Belgrade, Serbia at 1 site in Serbia.
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 5 inclusion and 4 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 7 Sep 2015. 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 Serbia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Jebsen Taylor Test of Hand Function (time frame: one day, two weeks and one month). 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 7 Sep 2015.