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

Alzheimer's Disease Clinical Trial

— ALSTICO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873546
• Other study ID #: API/2011/24
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: October 12, 2017
• Start date: July 19, 2013
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Pierre Vandel, MD PhD
• Phone: +33381219007
• Email: pierre.vandel[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Aphasia
• Aphasia, Primary Progressive
• Early or Mild State
• Frontotemporal Dementia
• Pick Disease of the Brain
• Progressive Primary Aphasia

Intervention

Device:
• transcranial 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.

Locations

Country	Name	City	State
France	CHU Besancon - Clinical Psychiatric Department	Besancon
France	Hopital Universitaire Dijon	Dijon
France	Assistance Publique - Hôpitaux Paris	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Assistance Publique - Hôpitaux de Paris, Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

References & Publications (1)

Bereau M, Sylvestre G, Mauny F, Puyraveau M, Baudier F, Magnin E, Berger E, Vandel P, Galmiche J, Chopard G. [Assessment of 10 years of memory consultations in the Franche-Comté: Description and analysis of the RAPID regional database]. Rev Neurol (Paris). 2015 Sep;171(8-9):655-61. doi: 10.1016/j.neurol.2015.04.008. Epub 2015 Jul 23. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline cognitive functions at 3 weeks	neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)	baseline, day 5 and 3 weeks post-tDCS