StrokeNCT01927458
Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke
A study testing Transcranial Direct Current Stimulation in people with Stroke and Neurorehabilitation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Neurorehabilitation
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Onset of stroke less than 14 days
- First ischemic stroke causing lower limb weakness (MRC score ≤4 in knee extensors) and gait impairment
Who cannot join
- Contraindications to MRI or TMS
- Other neurological disorders
- Significant somatic or psychiatric disorders
- History of seizures
- Language or cognitive disorders prohibiting participation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.
- Conditions
- Stroke, Neurorehabilitation
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called Non.invasive brain stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS with treadmill training | Experimental | Each subject will receive 4 weeks gait treadmill training at least 3 days per week in combination with anodal transcranial Direct Current Stimulation over the primary motor cortex up to 20 min Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal gait speed using the 10-m walking test
Measured: Baseline and follow up immediately following the 4 weeks intervention
Secondary outcomes (2)
Changes in cortical excitability measures
We will measure cortical excitability using single pulse transcranial magnetic stimulation (TMS) before and after 1st stimulation session. We will compare the measurements from before stimulation to after stimulation.
Measured: Baseline
Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer
Measured: Baseline and immediately following the 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Slow recruitment rate
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystian Figlewski, University of Aarhus
- Investigators
- Henning Andersen, Professor, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927458
- Sponsor's protocol ID
- M-2012-570-12
- Status last verified
- Feb 2017
- First submitted
- 15 Aug 2013
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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 Aided Rehabilitation of Gait in Subacute Stroke
- ClinicalTrials.gov ID
- NCT01927458
- Acronym / sponsor ID
- M-2012-570-12
- Conditions
- Stroke, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Aug 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 purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS with treadmill training | Experimental | Device: Transcranial Direct Current StimulationEach subject will receive 4 weeks gait treadmill training at least 3 days per week in combination with anodal transcranial Direct Current Stimulation over the primary motor cortex up to 20 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Onset of stroke less than 14 days
- First ischemic stroke causing lower limb weakness (MRC score ≤4 in knee extensors) and gait impairment
Key exclusion criteria (5 listed)
- Contraindications to MRI or TMS
- Other neurological disorders
- Significant somatic or psychiatric disorders
- History of seizures
- Language or cognitive disorders prohibiting participation
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 Direct Current StimulationAlso: Non.invasive brain stimulationA direct current runs between two electrode positions and affects the excitability of the underlying brain tissue | Device | anodal tDCS with treadmill training |
Primary outcome
Maximal gait speed using the 10-m walking test
Time frame: Baseline and follow up immediately following the 4 weeks intervention
2 secondary outcomes
Changes in cortical excitability measures
Time frame: Baseline
Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer
Time frame: Baseline and immediately following the 4 weeks intervention
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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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
University of Aarhus
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 Direct Current Stimulation in people with Stroke and Neurorehabilitation, 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 3 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: stopped early, 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. 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 was stopped early (reason given: Slow recruitment rate). 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?
Maximal gait speed using the 10-m walking test (time frame: Baseline and follow up immediately following the 4 weeks intervention). 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 Feb 2017.