Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study

NCT ID: NCT02703870

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.

Detailed Description

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Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.

19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP, Connectivity, Spectral Power, ...)

Conditions

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Hemianopia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Verum tDCS

Verum group receiving complete treatment of tDCS

Group Type ACTIVE_COMPARATOR

verum tDCS

Intervention Type DEVICE

real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes

VRT

Intervention Type BEHAVIORAL

Vision restoration training, 10 sessions, 20 minutes

sham tDCS

Sham group receiving sham tDCS

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

sham transcranial direct current stimulation, 10 sessions, for 20 minutes

VRT

Intervention Type BEHAVIORAL

Vision restoration training, 10 sessions, 20 minutes

real VRT

Real Vision Restoration Training

Group Type ACTIVE_COMPARATOR

verum tDCS

Intervention Type DEVICE

real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes

sham tDCS

Intervention Type DEVICE

sham transcranial direct current stimulation, 10 sessions, for 20 minutes

Interventions

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verum tDCS

real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes

Intervention Type DEVICE

sham tDCS

sham transcranial direct current stimulation, 10 sessions, for 20 minutes

Intervention Type DEVICE

VRT

Vision restoration training, 10 sessions, 20 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Posterior Cerebral Artery Stroke
* Visual Field Defect
* Lesion age 4 weeks up to 6 month max.

Exclusion Criteria

* Electrical Implants
* Metal artefacts in head
* Epilepsy
* Visual Neglect
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurologisches Therapiezentrum Gmundnerberg

OTHER

Sponsor Role collaborator

University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Bernhard A. Sabel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard A Sabel, Prof. Dr.

Role: STUDY_DIRECTOR

Institute of Medical Psychology

Locations

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Neurologisches Therapiezentrum Gmundnerberg

Altmünster, , Austria

Site Status

Inst. f. Medical Psychology, Univ. of Magdeburg

Magdeburg, , Germany

Site Status

Countries

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Austria Germany

Other Identifiers

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CES_NTG_1

Identifier Type: -

Identifier Source: org_study_id

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