Transcranial Direct Current Stimulation and Early Alzheimer's Disease (tDCS-AD)

NCT03288363 | Unknown

• 1 other identifier: 2016-A01527-44
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research. Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy. The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) for a three-month period.

Conditions

Alzheimer Disease

Keywords

tDCS; cognition

Outcome Measures

Primary Outcomes (1)

• Comparing between the active tDCS group with the placebo tDCS group, the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) score, 12 weeks after the start of the course, in subjects with early Alzheimer's disease

  difference of ADAS-Cog psychometric scale score between sham and stimulation groups

  3 months

Study Arms (2)

tDCS

EXPERIMENTAL

20 sessions tDCS (DC-Stimulator Plus -Neuroconn) during 2 Weeks on temporal cortex - each session : 30 minutes - 2 mA - 2 sessions per day - evaluation at 12 weeks post-treatment

Device: tDCS

sham stimulation

SHAM COMPARATOR

the same parameters of stimulation as with real current stimulation (time, parameters to be seen on the apparatus screen) 20 sessions during 2 Weeks on temporal cortex - each session : 30 minutes - 2 sessions per day.

Device: tDCS

Interventions

tDCS DEVICE

20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)

Also known as: transcranial direct current stimulation

sham stimulation; tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A man or woman with probable Alzheimer's disease diagnosed according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA)
• Age ≥ 60 years
• Mini Mental State Examination ≥ 18
• Clinical Demential Rating ≤ 1
• Availability of a caregiver for assessments
• Patient care in Day Hospital
• Informed consent of the subject or his legal representative
• General somatic state consistent with study procedures

You may not qualify if:

• Presentation of contraindications to tDCS (presence of intracranial metal implants, intracranial hypertension, comitial risk).
• In case of anticholinesterase treatment: taken for at least 6 months and at a non stable dose for 4 months.
• Taking an antagonist treatment of NMDA receptors (anodic and cathodic) which cancels post-stimulation effects (memantine).
• Other types of dementia or neurological disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, Huntington's disease, stroke, major head trauma, cerebral neoplasia, systemic disease ...) , Which can lead to alterations in the functioning of the central nervous system.
• psychiatric disorder according to DSM-5, other than Alzheimer's disease including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, major depressive episode in progress, psychosis, panic attacks, post traumatic stress disorder And / or cognitive impairment not otherwise specified.
• Any other disorder for which treatment is given priority over the treatment of Alzheimer's disease or is likely to interfere with the study treatment or impairing adherence.
• Accommodation in an institution (EHPAD, EHPA) or request in progress.
• Participation in other biomedical research during the study that may interfere with the objectives of the study.
• Person who had a recent change (\<1 month) of psychotropic treatment.
• Person with a place of residence more than 80 km away.
• Person without health insurance.

Sponsors & Collaborators

• Benjamin CALVET: lead

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87025, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Benjamin Calvet, MD, PhD

  Centre Hospitalier Esquirol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murielle Girard, PhD

CONTACT

0033555431028; murielle.girard@ch-esquirol-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the operator enters in the tDCS apparatus the code number of the kind of stimulation to deliver; This code number has been randomly assigned, and the correspondence list is not accessible by the different research professionals.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: sham versus stimulation

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: September 20, 2017
• Study Start: June 6, 2017
• Primary Completion: June 6, 2024
• Study Completion: December 6, 2024
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

FR (1)