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

Mild Cognitive Impairment Clinical Trial

— STIMCI  

Official title:

Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment: A Proof-of-principle Study and Neural Correlates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771211
• Other study ID #: FL379101
• Status: Completed
• Phase: N/A
• First received: January 14, 2013
• Last updated: August 20, 2013
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

Previous studies showed that anodal transcranial direct current stimulation (atDCS) can have beneficial effects on word-retrieval in healthy younger and older subjects. The present study aims to extend these findings by assessing whether atDCS can also improve known impairments of word-retrieval in Mild Cognitive Impairment. atDCS will be applied to the left inferior frontal gyrus in a sham controlled cross-over within subjects design. Simultaneous functional magnetic resonance imaging (fMRI) will assess underlying neural effects of the stimulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 86 Years

Eligibility

Inclusion Criteria:

• right handed

• German native speakers

• clinical diagnosis of Mild Cognitive Impairment

Exclusion Criteria:

• dementia

• other current or previous neurological or current psychiatric diseases

• alcohol or drug abuse

• MRI contraindication (e.g., magnetic metal, pacemaker, claustrophobia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Device:
• tDCS
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.

Locations

Country	Name	City	State
Germany	Charite University Medicine, Department of Neurology	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No