Late LTP-like Plasticity Effects of tDCS in Subacute Stro... | NCT02393651

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

NCT02393651

Sponsor

Erasmus Medical Center

Status

Unknown status

Last Update Posted

Nov 28, 2018Actual

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Stroke
Hemiparesis

Interventions

tDCS

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NL49887.078.14	Other Identifier	CCMO

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

May 2019Estimated

Completion Date

May 2019Estimated

First Submitted Date

Mar 15, 2015

First Submission Date that Met QC Criteria

Mar 18, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2018

Last Update Posted Date

Nov 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rick van der Vliet, MSc, Erasmus Medical CenterPrincipal Investigator

Lead Sponsor

Erasmus Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
tDCS	Device	Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.	Sham tDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Upper Extremity Fugl Meyer Assessment		Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rick van der Vliet, MSc	Contact	+31622857402		r.vandervliet@erasmusmc.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijndam	Recruiting	Rotterdam	South Holland	3015LJ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33175411	Derived	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.

ID	Term
D020521	Stroke
D010291	Paresis

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies