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

C

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

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)

Trial contacts and locations

3

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Central trial contact

Pierre Vandel, MD PhD; Magali Nicolier, PhD

Data sourced from clinicaltrials.gov

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