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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935413
• Other study ID #: CES_NTG_Pilot
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 13, 2016
• Last updated: October 13, 2016
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2016
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemianopia
• Hemianopsia
• Stroke

Intervention

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

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

Locations

Country	Name	City	State
Austria	Neurologisches Therapiezentrum Gmundnerberg	Altmuenster
Germany	Inst. f. Medical Psychology, Univ. of Magdeburg	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	Neurologisches Therapiezentrum Gmundnerberg

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention		14-20 days post treatment,	No