TDCS in Acute Stroke

Stroke Clinical Trial

— TDCS-aphasia  

Official title:

Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01701713
• Other study ID #: TDCS_CSB-Brandenburg
• Secondary ID: EA4/109/08
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2012
• Last updated: October 5, 2012
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: October 2012
• Source: Charite University, Berlin, Germany
• Contact: Gerhard J Jungehuelsing, MD
• Email: jan.jungehuelsing[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee Charité
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.

Description:

TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• first media stroke

• language impairment

• informed consent

• right handedness

• NIHSS < 20

Exclusion Criteria:

• previous Epilepsy oder epileptogenic events

• epilepsy typical elements in EEG

• hypersensitive skin (head)

• metal implants (head)

• pace maker or other electronic implants

• previous head/brain surgery

• medication reducing seizure threshold

• previous psychiatric events

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• DKI ED2011

• Sham-TDCS

Locations

Country	Name	City	State
Germany	Charité, Campus Benjamin Franklin, Dep. of Neurology	Berlin
Germany	Brandenburg Klinik Bernau	Bernau	Brandenburg

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Brandenburg Klinik, Bernau, Germany, German Federal Ministry of Education and Research, University of Potsdam

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin irritation		2 months	Yes
Secondary	Improved language	improved picture naming	2 months	No