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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703870
• Other study ID #: CES_NTG_1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 18, 2015
• Last updated: March 3, 2016
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: March 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.

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, ...)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemianopia
• Stroke

Intervention

Device:
• verum tDCS
real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes
• sham tDCS
sham transcranial direct current stimulation, 10 sessions, for 20 minutes

Behavioral:
• VRT
Vision restoration training, 10 sessions, 20 minutes

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 and follow up		14-20 days post treatment, 3 months follow up	No
Secondary	Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up	power spectra (Volts-squared per Hz (V^2/Hz)	14-20 days post treatment, 3 months follow up	No
Secondary	Change in VEP latencies (ms) from baseline to post-intervention and follow up	VEP latencies (ms)	14-20 days post treatment, 3 months follow up	No
Secondary	Change in VEP amplitudes (µV) from baseline to post-intervention and follow up	VEP amplitudes (µV)	14-20 days post treatment, 3 months follow up	No
Secondary	Change in network coherence from baseline to post-intervention and follow up	network coherence correlations	14-20 days post treatment, 3 months follow up	No
Secondary	Number of participants with treatment-related adverse events assessed by a questionnaire	questionnaire recording adverse effects	up to 4 months	No