NCT02399540

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

March 15, 2015

Last Update Submit

August 1, 2016

Conditions

StrokeHemiparesis

Outcome Measures

Primary Outcomes (1)

  • Motor Skill Retention

    Motor skill retention will be assessed on the circuit game

    Day 9

Secondary Outcomes (2)

  • Maximum Grip Force

    Day 1 and Day 9

  • Purdue Pegboard Test

    Day 1 and Day 9

Study Arms (4)

Sham

SHAM COMPARATOR

Day 1: sham stimulation Day 2: sham stimulation

Device: Sham

Conventional Paired tDCS

ACTIVE COMPARATOR

Day 1: sham stimulation Day 2: conventional tDCS

Device: Conventional Paired tDCS

Conventional Unpaired tDCS

ACTIVE COMPARATOR

Day 1: conventional tDCS Day 2: sham stimulation

Device: Conventional Unpaired tDCS

Late LTP-like Plasticity tDCS

EXPERIMENTAL

Day 1: late LTP-like Plasticity tDCS Day 2: sham stimulation

Device: Late LTP-like Plasticity tDCS

Interventions

ShamDEVICE

Bihemispheric 1mA Sham protocol: sham - pause - sham

Sham
Conventional Paired tDCSDEVICE

Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Paired tDCS protocol: 20 minutes tDCS - pause - sham

Conventional Paired tDCS
Conventional Unpaired tDCSDEVICE

Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Unpaired tDCS protocol: 20 minutes tDCS - pause - sham

Conventional Unpaired tDCS
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

Late LTP-like Plasticity tDCS

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic (\> 6 months) stroke patient
  • Aged 18-79 years
  • Motor deficit in the upper limb due to the stroke

You may not qualify if:

  • 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
  • Taking anticonvulsant or neuroleptic medication
  • Substance abuse
  • Inability to understand instructions
  • History of psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijndam

Rotterdam, South Holland, 3015LJ, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 23316151RESULT

  • 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.

    PMID: 33175411DERIVED

  • van 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.

    PMID: 28751226DERIVED

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

March 15, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations

NL(1)