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

NCT02393651 | Unknown

• 2 other identifiers: MEC-2014-503NL49887.078.14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Upper Extremity Fugl Meyer Assessment

  Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks

Secondary Outcomes (8)

• ARAT

  Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks

• Hand grip strength

  Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks

• 10-meter walk test

  Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks

• EuroQol-5D

  12 weeks

• Barthel Index

  Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks

Study Arms (2)

Sham

PLACEBO COMPARATOR

Motor training of the affected upper extremity combined with sham tDCS.

Device: tDCS

tDCS

EXPERIMENTAL

Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).

Device: tDCS

Interventions

tDCS DEVICE

Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.

Sham; tDCS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Rijndam

Rotterdam, South Holland, 3015LJ, Netherlands

RECRUITING

Related Publications (1)

• 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: 33175411 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Rick van der Vliet, MSc

CONTACT

+31622857402; r.vandervliet@erasmusmc.nl

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 19, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

NL (1)