Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment

NCT01771211 | Completed

• 1 other identifier: FL379101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if non-invasive electrical brain stimulation can improve word-retrieval in Mild Cognitive Impairment (MCI).

Conditions

Mild Cognitive Impairment

Keywords

MCI; Word-retrieval; tDCS; fMRI

Outcome Measures

Primary Outcomes (1)

• Number of correct responses during word-generation tasks (max. 60)

  Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during sham stimulation or active stimulation with transcranial direct current stimulation. Order of stimulation (sham, atDCS or atDCS, sham) will be counterbalanced across the group. The study design has been described in detail before (Meinzer et al., 2012, Journal of Neuroscience, 32:1859 -1866).

  Change in number of correct responses between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week

Secondary Outcomes (1)

• Neural activity during word-generation task assessed by functional magnetic resonance imaging (fMRI)

  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

anodal tDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left inferior frontal gyrus

Device: tDCS

sham tDCS

SHAM COMPARATOR

sham tDCS will be administered to the left inferior frontal gyrus

Device: tDCS

Interventions

tDCS DEVICE

anodal tDCS will be delivered with a constant current of 1 mA during resting-state and task-related fMRI and will continue until the end of the word-generation task. For both stimulation conditions (atDCS, sham) the current will be initially increased in a ramp-like fashion over 10 s, eliciting a tingling sensation on the scalp that fades over seconds. During sham stimulation the current will be turned off after 30 s.

Also known as: DC-Stimulator Plus, neuroConn GmbH

anodal tDCS; sham tDCS

Eligibility Criteria

• Age: 45 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• right handed
• German native speakers
• clinical diagnosis of Mild Cognitive Impairment

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Foundation: collaborator

Study Sites (1)

Charite University Medicine, Department of Neurology

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Agnes Flöel, MD

  Charite University Medicine, Department of Neurology

  PRINCIPAL INVESTIGATOR

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: Creutzfeld Fellow

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 18, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

DE (1)