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

Sponsor

Erasmus Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02399540

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiparesis	Device: Sham Device: Conventional Paired tDCS Device: Conventional Unpaired tDCS Device: Late LTP-like Plasticity tDCS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Day 1: sham stimulation Day 2: sham stimulation	Device: Sham Bihemispheric 1mA Sham protocol: sham - pause - sham
Active Comparator: Conventional Paired tDCS Day 1: sham stimulation Day 2: conventional tDCS	Device: Conventional Paired tDCS Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Paired tDCS protocol: 20 minutes tDCS - pause - sham
Active Comparator: Conventional Unpaired tDCS Day 1: conventional tDCS Day 2: sham stimulation	Device: Conventional Unpaired tDCS Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Unpaired tDCS protocol: 20 minutes tDCS - pause - sham
Experimental: Late LTP-like Plasticity tDCS Day 1: late LTP-like Plasticity tDCS Day 2: sham stimulation	Device: Late LTP-like Plasticity tDCS Bihemispheric 1mA Sham protocol: sham - pause - sham Late LTP-like Plasticity tDCS protocol: 10 minutes tDCS - 25 minutes pause - 10 minutes tDCS

Outcome Measures

Primary Outcome Measures

Motor Skill Retention [Day 9]
Motor skill retention will be assessed on the circuit game

Secondary Outcome Measures

Maximum Grip Force [Day 1 and Day 9]
Maximum Grip Force will be assessed using a Jamar Dynamometer
Purdue Pegboard Test [Day 1 and Day 9]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijndam	Rotterdam	Zuid-Holland	Netherlands	3015LJ

Sponsors and Collaborators

Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rick van der Vliet, MSc, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT02399540

Other Study ID Numbers:

MEC-2014-203

First Posted:

Mar 26, 2015

Last Update Posted:

Aug 2, 2016

Last Verified:

Aug 1, 2016

Additional relevant MeSH terms:

Stroke

Paresis

Study Results

No Results Posted as of Aug 2, 2016