TDCS in Acute Stroke | NCT01701713

Studies
TDCS in Acute Stroke

NCT01701713

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Oct 8, 2012Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

DKI ED2011
Sham-TDCS

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EA4/109/08	Other Identifier	Charité Ethics Committee

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Sep 26, 2012

First Submission Date that Met QC Criteria

Oct 4, 2012

First Posted Date

Oct 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2012

Last Update Posted Date

Oct 8, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerhard Jan Jungehuelsing, MD, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV
Brandenburg Klinik, Bernau, Germany	UNKNOWN
University of Potsdam	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TDCS - DKI ED2011	Experimental	TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues	Device: DKI ED2011
Sham-TDCS	Sham Comparator	Sham-TDCS session is followed by a behavioral naming therapy with different cues	Device: Sham-TDCS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DKI ED2011	Device		TDCS - DKI ED2011
Sham-TDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
skin irritation		2 months

Secondary Outcomes

Measure	Description	Time Frame
Improved language	improved picture naming	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gerhard J Jungehuelsing, MD	Contact			jan.jungehuelsing@charite.de
Isabell Wartenburger, Prof. MD	Contact			isabell.wartenburger@uni-potsdam.de

Overall Officials

Name	Affiliation	Role
Gerhard J Jungehuelsing, MD	Center for Stroke Research Berlin (CSB), Charité	Principal Investigator
Michael Joebges, Prof. MD	Brandenburgklinik Bernau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brandenburg Klinik Bernau	Recruiting	Bernau bei Berlin	Brandenburg	16321	Germany

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D001037	Aphasia

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided