Chronic Aphasia - Improved by Intensive Training and Elec... | NCT01221779

Studies
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation

NCT01221779

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Aug 27, 2013Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Post-Stroke Chronic Aphasia
Anomia (Word-retrieval Impairment)

Interventions

Intensive language therapy
Intensive language therapy

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

Status Module

Record Verification Date

Aug 2013

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

Jan 2011

Primary Completion Date

Aug 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Oct 13, 2010

First Submission Date that Met QC Criteria

Oct 14, 2010

First Posted Date

Oct 15, 2010Estimated

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

Aug 26, 2013

Last Update Posted Date

Aug 27, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcus Meinzer, Creutzfeldt Fellow, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia

Detailed Description

Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.

Thus, in the present project we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sham tDCS	Placebo Comparator		Behavioral: Intensive language therapy
anodal tDCS	Experimental		Behavioral: Intensive language therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensive language therapy	Behavioral	2 weeks of daily computerized naming training, daily, 3 hours	sham tDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Boston Naming Test		Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

Secondary Outcomes

Measure	Description	Time Frame
Boston Naming Test	The follow-up will be administered to assess the stability of the treatment gains	Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Naming performance during functional magnetic resonance scanning

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

right-handedness
single first time left-hemisphere stroke
fluent- or non-fluent chronic aphasia (more than six months post-stroke)
anomia (PR>10 and PR<60 Aachen Aphasia Naming Subtest)
native German Speaker

Exclusion Criteria:

more than one stroke
alcoholism, severe psychiatric conditions, other neurological conditions
other non-treated medical problems, severe microangiopathy
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcus Meinzer, PhD	Contact	+49-(0)30-450-560	140	marcus.meinzer@charite.de
Agnes Flöel, MD	Contact	+49-(0)30-450-560	284	agnes.floeel@charite.de

Overall Officials

Name	Affiliation	Role
Marcus Meinzer, PhD	Charite, University Medicine, Neurology	Principal Investigator
Agnes Flöel, MD	Charite, University Medicine, Neurology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite, University Medicine, Dept. of Neurology	Recruiting	Berlin			Germany

Condition Browse Module

MeSH Terms

ID	Term
D000849	Anomia

Ancestor Terms

ID	Term
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided