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
• Interventions: Device: transcranial Direct Current Stimulation (tDCS)

• 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

Arm && Interventions

Group	Intervention	Description
anodal tDCS on left DLPFC (F3)	transcranial Direct Current Stimulation (tDCS)	tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 minutes for 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair.
sham tDCS on left DLPFC (F3)	transcranial Direct Current Stimulation (tDCS)	Sham tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 minutes - 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair.

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)

Assistance Publique - Hôpitaux Paris; 🇫🇷 Paris, France

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

Hopital Universitaire Dijon; 🇫🇷 Dijon, France