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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935413
Other study ID # CES_NTG_Pilot
Secondary ID
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


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
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