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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399540
• Other study ID #: MEC-2014-203
• Status: Completed
• Phase: N/A
• First received: March 15, 2015
• Last updated: August 1, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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

Locations

Country	Name	City	State
Netherlands	Rijndam	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Skill Retention	Motor skill retention will be assessed on the circuit game	Day 9	No
Secondary	Maximum Grip Force	Maximum Grip Force will be assessed using a Jamar Dynamometer	Day 1 and Day 9	No
Secondary	Purdue Pegboard Test		Day 1 and Day 9	No