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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

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

Treatments: Device: transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02873546

API/2011/24

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

anodal tDCS on left DLPFC (F3)

Active Comparator group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)

sham tDCS on left DLPFC (F3)

Sham Comparator group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)