Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients

November 27, 2018 updated by: Rick van der Vliet, Erasmus Medical Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015LJ
        • Recruiting
        • Rijndam
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sham
Motor training of the affected upper extremity combined with sham tDCS.
Device: tDCS
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
Experimental: tDCS
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Device: tDCS
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Upper Extremity Fugl Meyer Assessment
Time Frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ARAT
Time Frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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
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
Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
EuroQol-5D
Time Frame: 12 weeks
12 weeks
Barthel Index
Time Frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
HADS
Time Frame: Baseline; 4 weeks and 12 weeks
Baseline; 4 weeks and 12 weeks
MoCA
Time Frame: Baseline; 4 weeks and 12 weeks
Baseline; 4 weeks and 12 weeks
Wong-Baker FACES Pain Rating Scale
Time Frame: Every stimulation session
Every stimulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

March 15, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2014-503
  • NL49887.078.14 (Other Identifier: CCMO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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