StrokeNCT01983319
tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
A study testing active anodal transcranial Direct Current Stimulation (tDCS) and Constraint Induced Movement Therapy (CIMT) in people with Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- active anodal transcranial Direct Current Stimulation (tDCS) and Constraint Induced Movement Therapy (CIMT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke onset >3 months prior to study enrollment
- subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
- subject can move, stand up and stand firmly with constrained healthy hand
- subject can perform training 6 hours daily in 2 weeks
- subject is able to understand instructions and be able to cooperate
Who cannot join
- pregnancy
- contraindications to MRI of brain
- epilepsy, major psychiatric disease
- excessive pain that prevents training
- history of other diseases resulting decreased mobility of affected upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.
- Conditions
- Stroke
- Being tested
- active anodal transcranial Direct Current Stimulation (tDCS), sham transcranial Direct Current Stimulation, Constraint Induced Movement Therapy (CIMT)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active anodal transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS, Non invasive brain stimulation, transcranial stimulation
Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT
sham transcranial Direct Current StimulationDevice
Also called placebo stimulation
sham transcranial Direct Current Stimulation 30 min with CIMT
Constraint Induced Movement Therapy (CIMT)Behavioural
Also called CIMT
2 weeks of CIMT
| Study group | Role | What they receive |
|---|---|---|
| CIMT + active anodal tDCS | Experimental | Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min. Receives: Device: active anodal transcranial Direct Current Stimulation (tDCS); Behavioral: Constraint Induced Movement Therapy (CIMT) |
| CIMT + sham tDCS | Sham comparator | Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation Receives: Device: sham transcranial Direct Current Stimulation; Behavioral: Constraint Induced Movement Therapy (CIMT) |
| Healthy control subjects | No intervention | 20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb function
The motor function assessment will be done with: Wolf Motor Function Test
Measured: Baseline and posttest (an average of 2 weeks from baseline)
Secondary outcomes (1)
GABA (gamma-aminobutyric acid) activity
Assessment of GABA activity using MRI spectroscopy. Measurements will be compared between patients undergoing CIMT and healthy subjects.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter, Aarhus University Hospital
- Responsible party
- Principal investigator, Krystian Figlewski, University of Aarhus
- Investigators
- Henning Andersen, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983319
- Sponsor's protocol ID
- M-2013-268-13
- Status last verified
- Feb 2017
- First submitted
- 31 Oct 2013
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.
PubMed 27899754
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
- ClinicalTrials.gov ID
- NCT01983319
- Acronym / sponsor ID
- M-2013-268-13
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter, Aarhus University Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Nov 2013 (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.
The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CIMT + active anodal tDCS | Experimental | Device: active anodal transcranial Direct Current Stimulation (tDCS), Behavioral: Constraint Induced Movement Therapy (CIMT)Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving active anodal transcranial Direct Current Stimulation 1,5 mA for 30 min. |
| CIMT + sham tDCS | Sham comparator | Device: sham transcranial Direct Current Stimulation, Behavioral: Constraint Induced Movement Therapy (CIMT)Subjects in this group will be trained with constraint-induced movement therapy for the hand (10 consecutive sessions Monday- Friday) while concurrently receiving sham transcranial Direct Current Stimulation |
| Healthy control subjects | No intervention | –20 healthy age-matched control subjects will undergo MRI spectroscopy of the brain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stroke onset >3 months prior to study enrollment
- subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
- subject can move, stand up and stand firmly with constrained healthy hand
- subject can perform training 6 hours daily in 2 weeks
- subject is able to understand instructions and be able to cooperate
Key exclusion criteria (5 listed)
- pregnancy
- contraindications to MRI of brain
- epilepsy, major psychiatric disease
- excessive pain that prevents training
- history of other diseases resulting decreased mobility of affected upper limb
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 anodal transcranial Direct Current Stimulation (tDCS)Also: tDCS, Non invasive brain stimulation, transcranial stimulationAnodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT | Device | CIMT + active anodal tDCS |
| sham transcranial Direct Current StimulationAlso: placebo stimulationsham transcranial Direct Current Stimulation 30 min with CIMT | Device | CIMT + sham tDCS |
| Constraint Induced Movement Therapy (CIMT)Also: CIMT2 weeks of CIMT | Behavioural | CIMT + active anodal tDCS, CIMT + sham tDCS |
Primary outcome
Change in Upper Limb function
Time frame: Baseline and posttest (an average of 2 weeks from baseline)
The motor function assessment will be done with: Wolf Motor Function Test
1 secondary outcome
GABA (gamma-aminobutyric acid) activity
Time frame: Baseline
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 Feb 2017.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Derived from this study: PubMed 27899754Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.
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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.
Henning Andersen, Professor study director
Aarhus University 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 anodal transcranial Direct Current Stimulation (tDCS) and Constraint Induced Movement Therapy (CIMT) in people with Stroke, run by University of Aarhus at 1 site in Denmark.
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 5 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 Feb 2017. 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 Denmark. 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 in Upper Limb function (time frame: Baseline and posttest (an average of 2 weeks from baseline)). 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 NCT01983319, which also lists 2 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 7 Feb 2017.