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Completed

NCT Number: NCT02399540

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijndam

Rotterdam, South Holland, 3015LJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

SHAM

Device

Bihemispheric 1mA Sham protocol: sham - pause - sham

Conventional Paired tDCS

Device

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

Conventional Unpaired tDCS

Device

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

Late LTP-like Plasticity tDCS

Device

Bihemispheric 1mA Sham protocol: sham - pause - sham Late LTP-like Plasticity tDCS protocol: 10 minutes tDCS - 25 minutes pause - 10 minutes tDCS

Primary outcomes

  1. Motor Skill Retention

    Time frame: Day 9

    Motor skill retention will be assessed on the circuit game

Secondary outcomes

  1. Maximum Grip Force

    Time frame: Day 1 and Day 9

    Maximum Grip Force will be assessed using a Jamar Dynamometer

  2. Purdue Pegboard Test

    Time frame: Day 1 and Day 9

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2015
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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