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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393651
• Other study ID #: MEC-2014-503
• Secondary ID: NL49887.078.14
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2019

Study information

• Verified date: November 2018
• Source: Erasmus Medical Center
• Contact: Rick van der Vliet, MSc
• Phone: +31622857402
• Email: r.vandervliet[@]erasmusmc.nl
• Is FDA regulated: No
• 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Upper Extremity Fugl Meyer Assessment		Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary	ARAT		Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary	Hand grip strength		Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary	10-meter walk test		Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary	EuroQol-5D		12 weeks
Secondary	Barthel Index		Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary	HADS		Baseline; 4 weeks and 12 weeks
Secondary	MoCA		Baseline; 4 weeks and 12 weeks
Secondary	Wong-Baker FACES Pain Rating Scale		Every stimulation session