Acute StrokeNCT04340973
Comparing Transcranial Direct Current Stimulation Montages in Stroke
A study testing Transcranial Direct Current Stimulation in people with Acute Stroke, run by University of Liege at 1 site in Belgium.
Trial summary
40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo. 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?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2020to 1 Jul 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: Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study
40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo.
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. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
Read the detailed description
40 acute subjects will be randomized and split into 5 groups.
Each group will receive one of the following tDCS montages :
Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down.
Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 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. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine
- Conditions
- Acute Stroke
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- tDCS, Acute Stroke, WMFT, SWMT, Fugl Meyer
- 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 tDCS
Subjects received a micro-current through their scalp to induce cortical and subcortical changes
| Study group | Role | What they receive |
|---|---|---|
| Anodal | Active comparator | Anodal tDCS: Anode placer 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: Transcranial Direct Current Stimulation |
| Bilateral | Active comparator | Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation, 5 days a week for 4 weeks Receives: Device: Transcranial Direct Current Stimulation |
| Cathodal | Active comparator | Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks Receives: Device: Transcranial Direct Current Stimulation |
| Extracephalic | Active comparator | Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks Receives: Device: Transcranial Direct Current Stimulation |
| Placebo | Placebo comparator | Placebo : 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: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wolf Motor Function Test
Functional upper limb test, filmed and scored subjectively
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Change in Fugl Meyer Motor Assessment
Functional upper limb, lower limb and sensory test
Measured: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Change in Semmes Weinstein Monofilament Test
11 Point Sensory test
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 posted10 Apr 2020
- Study start7 May 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 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
- 5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04340973
- Sponsor's protocol ID
- 2017-94
- Status last verified
- May 2020
- First submitted
- 4 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study
- ClinicalTrials.gov ID
- NCT04340973
- Acronym / sponsor ID
- 2017-94
- Conditions
- Acute Stroke
- Keywords
- tDCS, Acute Stroke, WMFT, SWMT, Fugl Meyer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 10 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.
40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo.
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. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
Detailed description
40 acute subjects will be randomized and split into 5 groups.
Each group will receive one of the following tDCS montages :
Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down.
Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 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. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study
| Arm | Type | Receives |
|---|---|---|
| Anodal | Active comparator | Device: Transcranial Direct Current StimulationAnodal tDCS: Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
| Bilateral | Active comparator | Device: Transcranial Direct Current StimulationBilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
| Cathodal | Active comparator | Device: Transcranial Direct Current StimulationCathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
| Extracephalic | Active comparator | Device: Transcranial Direct Current StimulationExtracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks |
| Placebo | Placebo comparator | Device: Transcranial Direct Current StimulationPlacebo : anode 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 |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSSubjects received a micro-current through their scalp to induce cortical and subcortical changes | Device | Anodal, Bilateral, Cathodal, Extracephalic, Placebo |
Primary outcome
Change in Wolf Motor Function Test
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Functional upper limb test, filmed and scored subjectively
Change in Fugl Meyer Motor Assessment
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Functional upper limb, lower limb and sensory test
Change in Semmes Weinstein Monofilament Test
Time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
11 Point Sensory test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
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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 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 19 May 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?
Change in Wolf Motor Function Test (time frame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4). The study lists 3 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 NCT04340973, 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 19 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.