tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia

Not Applicable

• Conditions: Progressive Primary Aphasia; Alzheimer's Disease; Early or Mild State

• Registration Number: NCT02873546
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment).

After unblinding, patients who received placebo treatment could be received active tDCS.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-19
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13
• Primary Completion: 2018-01-31
• Study Completion: 2018-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient)
• CDR score ≤ 2
• treatment by IAChE ≥ 3 months
• MADRS score < 18
• w/o severe progressive somatic pathology (especially tumor diseases)

Exclusion Criteria

• last neuropsychological assessment < 6 months
• presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from baseline cognitive functions at 3 weeks	baseline, day 5 and 3 weeks post-tDCS	neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)

Trial Locations

Locations (3)

CHU Besancon - Clinical Psychiatric Department; 🇫🇷 Besancon, France

Hopital Universitaire Dijon; 🇫🇷 Dijon, France

Assistance Publique - Hôpitaux Paris; 🇫🇷 Paris, France