StrokeNCT02393651
Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
A study testing tDCS in people with Stroke and Hemiparesis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to May 2019
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacute stroke (within 1-4 weeks post stroke)
- Acute hemiparesis (Fugl-Meyer Stage < IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist
- Aged 18-79
Who cannot join
- Absence of voluntary movement (Fugl-Meyer Stage < III)
- Head injury or the presence of intracranial metal or intracranial lesions
- History of cranial irradiation
- History of epilepsy
- Presence of a pacemaker
- Taking anticonvulsant or neuroleptic medication
- Substance abuse
- Inability to understand instructions
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Rijndam
Rotterdam, South Holland, 3015LJ
Gerard Ribbers, PhD MD, +31102412411, gribbers@rijndam.nl
About this study
Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.
Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.
- Conditions
- Stroke, Hemiparesis
- Being tested
- tDCS
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Placebo comparator | Motor training of the affected upper extremity combined with sham tDCS. Receives: Device: tDCS |
| tDCS | Experimental | Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS). Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Upper Extremity Fugl Meyer Assessment
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary outcomes (8)
ARAT
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Hand grip strength
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
10-meter walk test
Measured: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
EuroQol-5D
Measured: 12 weeks
Barthel Index
Measured: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
HADS
Measured: Baseline; 4 weeks and 12 weeks
MoCA
Measured: Baseline; 4 weeks and 12 weeks
Wong-Baker FACES Pain Rating Scale
Measured: Every stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (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 StrokeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rick van der Vliet, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393651
- Sponsor's protocol ID
- MEC-2014-503
- Other IDs
- NL49887.078.14
- Status last verified
- Nov 2018
- First submitted
- 15 Mar 2015
- Last updated
- 28 Nov 2018
- 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 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT02393651
- Acronym / sponsor ID
- MEC-2014-503
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 19 Mar 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.
Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.
Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Placebo comparator | Device: tDCSMotor training of the affected upper extremity combined with sham tDCS. |
| tDCS | Experimental | Device: tDCSMotor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subacute stroke (within 1-4 weeks post stroke)
- Acute hemiparesis (Fugl-Meyer Stage < IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist
- Aged 18-79
Key exclusion criteria (8 listed)
- Absence of voluntary movement (Fugl-Meyer Stage < III)
- Head injury or the presence of intracranial metal or intracranial lesions
- History of cranial irradiation
- History of epilepsy
- Presence of a pacemaker
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 |
|---|---|---|
| tDCSLate LTP-like plasticity tDCS (2 times per week) for 4 weeks. | Device | Sham, tDCS |
Primary outcome
Change from baseline in Upper Extremity Fugl Meyer Assessment
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
8 secondary outcomes
ARAT
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Hand grip strength
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
10-meter walk test
Time frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
EuroQol-5D
Time frame: 12 weeks
Barthel Index
Time frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
HADS
Time frame: Baseline; 4 weeks and 12 weeks
MoCA
Time frame: Baseline; 4 weeks and 12 weeks
Wong-Baker FACES Pain Rating Scale
Time frame: Every stimulation session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Stroke and Hemiparesis, run by Erasmus Medical Center at 1 site in Netherlands.
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 8 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 28 Nov 2018. 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 Netherlands. 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 Rick van der Vliet, MSc (+31622857402, r.vandervliet@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Upper Extremity Fugl Meyer Assessment (time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks). 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 NCT02393651, 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 28 Nov 2018.