Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia

NCT01845129 | Unknown

• 1 other identifier: RAPH_01EO0801
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.

Conditions

Residual Aphasia

Outcome Measures

Primary Outcomes (1)

• Response latency during picture naming task (max. 80)

  Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation. Order of stimulation will be counterbalanced across the group.

  Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week

Secondary Outcomes (1)

• Change in neural activity measured by functional magnetic resonance imaging

  Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week

Study Arms (2)

anodal tDCS

EXPERIMENTAL

atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex

Device: atDCS; Device: sham tDCS

sham tDCS

SHAM COMPARATOR

sham tDCS will be administered to the left primary hand motor cortex

Device: atDCS; Device: sham tDCS

Interventions

atDCS DEVICE

atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.

anodal tDCS; sham tDCS

sham tDCS DEVICE

During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)

anodal tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• right handedness
• German native speaker
• cerebrovascular stroke in left hemisphere (\>6 months)
• mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
• residual anomia in naming test (\>75 correct responses)

You may not qualify if:

• other current or previous neurological or psychiatric diseases
• alcohol or drug abuse
• MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite, University Medicine, Dept. of Neurology

Berlin, State of Berlin, 10117, Germany

RECRUITING

Study Officials

• Marcus Meinzer, PhD

  Charite, University Medicine, Neurology

  PRINCIPAL INVESTIGATOR

• Agnes Flöel, MD

  Charite, University Medicine, Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Darkow, MSc

CONTACT

+49 30 450 560; robert.darkow@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Creutzfeldt Fellow

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 3, 2013

Record last verified: 2013-04

Locations

DE (1)