Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study

NCT ID: NCT02935413

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

Brief Summary

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

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.

Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.

Conditions

Hemianopia; Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tDCS

group receiving complete treatment of transcranial direct current stimulation

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes

Standard rehabilitation

Standard rehabilitation procedures

Group Type: ACTIVE_COMPARATOR

Standard rehabilitation

Intervention Type: BEHAVIORAL

Standard rehabilitation procedures involving PC-based training of saccades and visual exploration

Interventions

tDCS

Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes

Intervention Type: DEVICE

Standard rehabilitation

Standard rehabilitation procedures involving PC-based training of saccades and visual exploration

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Neurologisches Therapiezentrum Gmundnerberg

OTHER

Sponsor Role: collaborator

University of Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Bernhard A. Sabel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raimund Alber, MS

Role: PRINCIPAL_INVESTIGATOR

Neurologisches Therapiezentrum Gmundnerberg

Locations

Neurologisches Therapiezentrum Gmundnerberg

Altmünster, , Austria

Inst. f. Medical Psychology, Univ. of Magdeburg

Magdeburg, , Germany

Countries

Austria; Germany

References

Alber R, Moser H, Gall C, Sabel BA. Combined Transcranial Direct Current Stimulation and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study. PM R. 2017 Aug;9(8):787-794. doi: 10.1016/j.pmrj.2016.12.003. Epub 2017 Jan 8.

Reference Type: DERIVED

PMID: 28082176 (View on PubMed)

Other Identifiers

CES_NTG_Pilot

Identifier Type: -

Identifier Source: org_study_id