StrokeNCT02399540
Late LTP-like Plasticity Effects of tDCS in Chronic Stroke Patients
A study testing Conventional Paired tDCS, Conventional Unpaired tDCS and Late LTP-like Plasticity 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?
- Conventional Paired tDCS, Conventional Unpaired tDCS and Late LTP-like Plasticity tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to May 2016
- 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
- Chronic (> 6 months) stroke patient
- Aged 18-79 years
- Motor deficit in the upper limb due to the stroke
Who cannot join
- Absence of recordable MEPs from the ADM after TMS
- Absence of voluntary movement (Fugl-Meyer < III)
- Head injury or the presence of intracranial metal or intracranial lesions
- History of cranial irradiation
- History of epilepsy
- Presence of a pacemaker
Show all 10Show fewer
- Taking anticonvulsant or neuroleptic medication
- Substance abuse
- Inability to understand instructions
- History of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
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. However, it is unknown how the motor cortex excitability changes that follow tDCS relate to the increase in motor learning and recovery potential. The currently upheld hypothesis is that motor learning needs to be synchronized in time with electrical stimulation (paired stimulation), but recent results from our lab suggest that tDCS also increases skill learning after stimulation has ended (unpaired stimulation). If this is true, tDCS has a much larger therapeutic window and is a more valuable clinical tool than currently believed. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects the increase in skill learning normally seen with tDCS when applied 24 hours before training. 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 tDCS in chronic stroke patients on skill learning 24 hours later.
Study design: Double-blinded, randomized between-subjects trials. Study population: Chronic stroke patients. Main study parameters/endpoints: The main objective of the study is to determine the effect of late LTP-like plasticity tDCS on skill learning 24 hours later. As a motor learning paradigm, the investigators will use a circuit tracking task which chronic stroke patients perform better if tDCS is applied concurrently. During this task, patients have to trace a cursor over a circuit as fast and accurately as possible by moving a computer mouse. Skill will be quantified by calculating a combined speed/ accuracy score and skill improvement compared to baseline (LI; the learning index) will be compared between the sham, conventional unpaired tDCS, conventional paired tDCS groups and the late LTP-like plasticity tDCS groups.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Sham, Conventional Paired tDCS, Conventional Unpaired tDCS, Late LTP-like Plasticity 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.
ShamDevice
Bihemispheric 1mA Sham protocol: sham - pause - sham
Conventional Paired tDCSDevice
Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Paired tDCS protocol: 20 minutes tDCS - pause - sham
Conventional Unpaired tDCSDevice
Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Unpaired tDCS protocol: 20 minutes tDCS - pause - sham
Late LTP-like Plasticity tDCSDevice
Bihemispheric 1mA Sham protocol: sham - pause - sham Late LTP-like Plasticity tDCS protocol: 10 minutes tDCS - 25 minutes pause - 10 minutes tDCS
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Day 1: sham stimulation Day 2: sham stimulation Receives: Device: Sham |
| Conventional Paired tDCS | Active comparator | Day 1: sham stimulation Day 2: conventional tDCS Receives: Device: Conventional Paired tDCS |
| Conventional Unpaired tDCS | Active comparator | Day 1: conventional tDCS Day 2: sham stimulation Receives: Device: Conventional Unpaired tDCS |
| Late LTP-like Plasticity tDCS | Experimental | Day 1: late LTP-like Plasticity tDCS Day 2: sham stimulation Receives: Device: Late LTP-like Plasticity tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Skill Retention
Motor skill retention will be assessed on the circuit game
Measured: Day 9
Secondary outcomes (2)
Maximum Grip Force
Maximum Grip Force will be assessed using a Jamar Dynamometer
Measured: Day 1 and Day 9
Purdue Pegboard Test
Measured: Day 1 and Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 84 participants (actual)
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
- NCT02399540
- Sponsor's protocol ID
- MEC-2014-203
- Status last verified
- Aug 2016
- First submitted
- 15 Mar 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lefebvre S, Laloux P, Peeters A, Desfontaines P, Jamart J, Vandermeeren Y. Dual-tDCS Enhances Online Motor Skill Learning and Long-Term Retention in Chronic Stroke Patients. Front Hum Neurosci. 2013 Jan 9;6:343. doi: 10.3389/fnhum.2012.00343. eCollection 2012.
PubMed 23316151Elsner 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 33175411van der Vliet R, Ribbers GM, Vandermeeren Y, Frens MA, Selles RW. BDNF Val66Met but not transcranial direct current stimulation affects motor learning after stroke. Brain Stimul. 2017 Sep-Oct;10(5):882-892. doi: 10.1016/j.brs.2017.07.004. Epub 2017 Jul 13.
PubMed 28751226
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late LTP-like Plasticity Effects of tDCS in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT02399540
- Acronym / sponsor ID
- MEC-2014-203
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 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. However, it is unknown how the motor cortex excitability changes that follow tDCS relate to the increase in motor learning and recovery potential. The currently upheld hypothesis is that motor learning needs to be synchronized in time with electrical stimulation (paired stimulation), but recent results from our lab suggest that tDCS also increases skill learning after stimulation has ended (unpaired stimulation). If this is true, tDCS has a much larger therapeutic window and is a more valuable clinical tool than currently believed. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects the increase in skill learning normally seen with tDCS when applied 24 hours before training. 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 tDCS in chronic stroke patients on skill learning 24 hours later.
Study design: Double-blinded, randomized between-subjects trials. Study population: Chronic stroke patients. Main study parameters/endpoints: The main objective of the study is to determine the effect of late LTP-like plasticity tDCS on skill learning 24 hours later. As a motor learning paradigm, the investigators will use a circuit tracking task which chronic stroke patients perform better if tDCS is applied concurrently. During this task, patients have to trace a cursor over a circuit as fast and accurately as possible by moving a computer mouse. Skill will be quantified by calculating a combined speed/ accuracy score and skill improvement compared to baseline (LI; the learning index) will be compared between the sham, conventional unpaired tDCS, conventional paired tDCS groups and the late LTP-like plasticity tDCS groups.
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 |
|---|---|---|
| Sham | Sham comparator | Device: ShamDay 1: sham stimulation Day 2: sham stimulation |
| Conventional Paired tDCS | Active comparator | Device: Conventional Paired tDCSDay 1: sham stimulation Day 2: conventional tDCS |
| Conventional Unpaired tDCS | Active comparator | Device: Conventional Unpaired tDCSDay 1: conventional tDCS Day 2: sham stimulation |
| Late LTP-like Plasticity tDCS | Experimental | Device: Late LTP-like Plasticity tDCSDay 1: late LTP-like Plasticity tDCS Day 2: sham stimulation |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic (> 6 months) stroke patient
- Aged 18-79 years
- Motor deficit in the upper limb due to the stroke
Key exclusion criteria (10 listed)
- Absence of recordable MEPs from the ADM after TMS
- Absence of voluntary movement (Fugl-Meyer < III)
- Head injury or the presence of intracranial metal or intracranial lesions
- History of cranial irradiation
- History of epilepsy
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 |
|---|---|---|
| ShamBihemispheric 1mA Sham protocol: sham - pause - sham | Device | Sham |
| Conventional Paired tDCSBihemispheric 1mA Sham protocol: sham - pause - sham Conventional Paired tDCS protocol: 20 minutes tDCS - pause - sham | Device | Conventional Paired tDCS |
| Conventional Unpaired tDCSBihemispheric 1mA Sham protocol: sham - pause - sham Conventional Unpaired tDCS protocol: 20 minutes tDCS - pause - sham | Device | Conventional Unpaired tDCS |
| Late LTP-like Plasticity tDCSBihemispheric 1mA Sham protocol: sham - pause - sham Late LTP-like Plasticity tDCS protocol: 10 minutes tDCS - 25 minutes pause - 10 minutes tDCS | Device | Late LTP-like Plasticity tDCS |
Primary outcome
Motor Skill Retention
Time frame: Day 9
Motor skill retention will be assessed on the circuit game
2 secondary outcomes
Maximum Grip Force
Time frame: Day 1 and Day 9
Purdue Pegboard Test
Time frame: Day 1 and Day 9
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 2 Aug 2016.
- Results publication: PubMed 23316151Lefebvre S, Laloux P, Peeters A, Desfontaines P, Jamart J, Vandermeeren Y. Dual-tDCS Enhances Online Motor Skill Learning and Long-Term Retention in Chronic Stroke Patients. Front Hum Neurosci. 2013 Jan 9;6:343. doi: 10.3389/fnhum.2012.00343. eCollection 2012.
- 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.
- Derived from this study: PubMed 28751226van der Vliet R, Ribbers GM, Vandermeeren Y, Frens MA, Selles RW. BDNF Val66Met but not transcranial direct current stimulation affects motor learning after stroke. Brain Stimul. 2017 Sep-Oct;10(5):882-892. doi: 10.1016/j.brs.2017.07.004. Epub 2017 Jul 13.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Paired tDCS, Conventional Unpaired tDCS and Late LTP-like Plasticity 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 10 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 2 Aug 2016. 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?
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?
Motor Skill Retention (time frame: Day 9). 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 NCT02399540, which also lists 3 linked publications.
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 2 Aug 2016.