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

Primary Purpose

Stroke, Hemiparesis

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
tDCS
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RijndamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sham

tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Upper Extremity Fugl Meyer Assessment

Secondary Outcome Measures

ARAT
Hand grip strength
10-meter walk test
EuroQol-5D
Barthel Index
HADS
MoCA
Wong-Baker FACES Pain Rating Scale

Full Information

First Posted
March 15, 2015
Last Updated
November 27, 2018
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02393651
Brief Title
Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
Official Title
Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
Motor training of the affected upper extremity combined with sham tDCS.
Arm Title
tDCS
Arm Type
Experimental
Arm Description
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in Upper Extremity Fugl Meyer Assessment
Time Frame
Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
ARAT
Time Frame
Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Title
Hand grip strength
Time Frame
Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Title
10-meter walk test
Time Frame
Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
Title
EuroQol-5D
Time Frame
12 weeks
Title
Barthel Index
Time Frame
Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
Title
HADS
Time Frame
Baseline; 4 weeks and 12 weeks
Title
MoCA
Time Frame
Baseline; 4 weeks and 12 weeks
Title
Wong-Baker FACES Pain Rating Scale
Time Frame
Every stimulation session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rick van der Vliet, MSc
Phone
+31622857402
Email
r.vandervliet@erasmusmc.nl
Facility Information:
Facility Name
Rijndam
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015LJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Ribbers, PhD MD
Phone
+31102412411
Email
gribbers@rijndam.nl

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
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.
Results Reference
derived

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

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