StrokePhase 2/3NCT02422173
Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
A Phase 2/3 study testing Anodal transcranial direct current stimulation, Cathodal transcranial direct current stimulation and Bilateral transcranial direct current stimulation in people with Stroke, run by Federal University of Paraíba.
Trial summary
Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Anodal transcranial direct current stimulation, Cathodal transcranial direct current stimulation and Bilateral transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2015
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute stroke
- Able to walk 10m independently
- High risk of falling
Who cannot join
- Severe functional limitations
- Cognitive impairment
About this study
Official title: Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial
Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.
Read the detailed description
This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.
- Conditions
- Stroke
- Being tested
- Anodal transcranial direct current stimulation, Cathodal transcranial direct current stimulation, Bilateral transcranial direct current stimulation, Sham 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.
Anodal transcranial direct current stimulationDevice
The active electrode is placed on the affected hemisphere
Cathodal transcranial direct current stimulationDevice
The active electrode is placed on the unaffected hemisphere
Bilateral transcranial direct current stimulationDevice
The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.
Sham transcranial direct current stimulationDevice
Placebo stimulation, with emission current by only 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation Receives: Device: Anodal transcranial direct current stimulation |
| Cathodal tDCS | Experimental | Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation Receives: Device: Cathodal transcranial direct current stimulation |
| Bilateral tDCS | Experimental | Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation Receives: Device: Bilateral transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four Square Step Test
Measured: Change from Baseline in Risk of Falls at 3 months
Secondary outcomes (6)
Occurrence of Falling Index
Measured: Baseline, Week 2, Week 4 and Week 12
Overall Stability Index
Measured: Baseline, Week 2, Week 4 and Week 12
Falls Efficacy Scale - International
Measured: Baseline, Week 2, Week 4 and Week 12
Berg Balance Scale
Measured: Baseline, Week 2, Week 4 and Week 12
Six-minute walk test
Measured: Baseline, Week 2, Week 4 and Week 12
Sit to Stand Test
Measured: Baseline, Week 2, Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionApr 2015
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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422173
- Sponsor's protocol ID
- tdcs002
- Status last verified
- Apr 2015
- First submitted
- 14 Apr 2015
- Last updated
- 21 Apr 2015
- 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 33175411
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02422173
- Acronym / sponsor ID
- tdcs002
- Conditions
- Stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Apr 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.
Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.
Detailed description
This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal transcranial direct current stimulationParticipants in the acute post-stroke stage will receive anodal transcranial direct current stimulation |
| Cathodal tDCS | Experimental | Device: Cathodal transcranial direct current stimulationParticipants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation |
| Bilateral tDCS | Experimental | Device: Bilateral transcranial direct current stimulationParticipants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Device: Sham transcranial direct current stimulationParticipants in the acute post-stroke stage will receive sham transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of acute stroke
- Able to walk 10m independently
- High risk of falling
Key exclusion criteria (2 listed)
- Severe functional limitations
- Cognitive impairment
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 stimulationThe active electrode is placed on the affected hemisphere | Device | Anodal tDCS |
| Cathodal transcranial direct current stimulationThe active electrode is placed on the unaffected hemisphere | Device | Cathodal tDCS |
| Bilateral transcranial direct current stimulationThe cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively. | Device | Bilateral tDCS |
| Sham transcranial direct current stimulationPlacebo stimulation, with emission current by only 30 seconds | Device | Sham tDCS |
Primary outcome
Four Square Step Test
Time frame: Change from Baseline in Risk of Falls at 3 months
6 secondary outcomes
Occurrence of Falling Index
Time frame: Baseline, Week 2, Week 4 and Week 12
Overall Stability Index
Time frame: Baseline, Week 2, Week 4 and Week 12
Falls Efficacy Scale - International
Time frame: Baseline, Week 2, Week 4 and Week 12
Berg Balance Scale
Time frame: Baseline, Week 2, Week 4 and Week 12
Six-minute walk test
Time frame: Baseline, Week 2, Week 4 and Week 12
Sit to Stand Test
Time frame: Baseline, Week 2, Week 4 and Week 12
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 21 Apr 2015.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anodal transcranial direct current stimulation, Cathodal transcranial direct current stimulation and Bilateral transcranial direct current stimulation in people with Stroke, run by Federal University of Paraíba.
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 2 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Four Square Step Test (time frame: Change from Baseline in Risk of Falls at 3 months). 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 NCT02422173, 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 21 Apr 2015.