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

Evaluation de l'Effet de la tDCS Sur Les Fonctions Cognitives de Patients Souffrant de Maladie d'Alzheimer et Maladies apparentées au Stade léger

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02873546
Acronym
ALSTICO
Enrollment
52
Registered
2016-08-19
Start date
2013-07-19
Completion date
2018-07-31
Last updated
2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Early or Mild State, Progressive Primary Aphasia

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.

Interventions

DEVICEtranscranial Direct Current Stimulation (tDCS)

After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 2 session per day during 5 consecutive days. Subjects will be monitored during tDCS sessions for any side effects or adverse events.

Sponsors

Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
change from baseline cognitive functions at 3 weeksbaseline, day 5 and 3 weeks post-tDCSneuropsychological assessments include Rapid battery tests (Bereay et al., 2015)

Countries

France

Contacts

Primary ContactPierre Vandel, MD PhD
pierre.vandel@univ-fcomte.fr+33381219007
Backup ContactMagali Nicolier, PhD
mnicolier@chu-besancon.fr+33381219007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026