Acute StrokeNCT04349488
Transcranial Direct Current Stimulation Acute Stroke Walking
A study testing Anodal Transcranial Direct Current Stimulation in people with Acute Stroke, run by University of Liege at 1 site in Belgium.
Trial summary
16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham. Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Anodal Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2020to 30 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First Ever Stroke
- Motor or sensory deficit
- Understands and follows orders
- Signed inform consent
Who cannot join
- One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Liege Univeristy Hospital
Liège, 4000
Stephen Bornheim, Msc
About this study
Official title: Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study
16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.
Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.
Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.
The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.
- Conditions
- Acute Stroke
- Being tested
- Anodal Transcranial Direct Current Stimulation
- Keywords
- Acute Stroke, tDCS, Anodal, Balance, Walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal Transcranial Direct Current StimulationDevice
Also called tDCS
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Anode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks Receives: Device: Anodal Transcranial Direct Current Stimulation |
| Placebo | Placebo comparator | Anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks Receives: Device: Anodal Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes Four Square Step Test
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Changes Berg Balance Scale
Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Changes Postural Assessment Scale For Stroke
alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Changes Trunk Impairment Scale
alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Changes Time Up & Go
To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Changes 10 meter walking test
10 meter walking test, the faster the better
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start16 Apr 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Model description
- One group receives anodal tDCS, one placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bornheim Stephen, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349488
- Sponsor's protocol ID
- 2016/287
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.
PubMed 30431445
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study
- ClinicalTrials.gov ID
- NCT04349488
- Acronym / sponsor ID
- 2016/287
- Conditions
- Acute Stroke
- Keywords
- Acute Stroke, tDCS, Anodal, Balance, Walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 16 Apr 2020 (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.
16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.
Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.
Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.
The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group receives anodal tDCS, one placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Anodal Transcranial Direct Current StimulationAnode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
| Placebo | Placebo comparator | Device: Anodal Transcranial Direct Current StimulationAnode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First Ever Stroke
- Motor or sensory deficit
- Understands and follows orders
- Signed inform consent
Key exclusion criteria (1 listed)
- One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
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 |
|---|---|---|
| Anodal Transcranial Direct Current StimulationAlso: tDCSSubjects received a micro-current through their scalp to induce cortical and subcortical changes | Device | Placebo, Treatment |
Primary outcome
Changes Four Square Step Test
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.
Changes Berg Balance Scale
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.
Changes Postural Assessment Scale For Stroke
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.
Changes Trunk Impairment Scale
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.
Changes Time Up & Go
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.
Changes 10 meter walking test
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
10 meter walking test, the faster the better
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Background: PubMed 30431445Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal Transcranial Direct Current Stimulation in people with Acute Stroke, run by University of Liege at 1 site in Belgium.
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 1 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 Apr 2020. 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 Belgium. 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 Stephen Bornheim, Msc (003243662193, stephen.bornheim@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes Four Square Step Test (time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4). The study lists 6 primary outcomes in all. 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 NCT04349488, which also lists 1 linked publication.
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 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.