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

Primary Purpose

Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

tDCS

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring tDCS, cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Centre Hospitalier EsquirolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS

sham stimulation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03288363

First Posted

September 17, 2017

Last Updated

October 21, 2021

Sponsor

Benjamin CALVET

1. Study Identification

Unique Protocol Identification Number

NCT03288363

Brief Title

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

Acronym

tDCS-AD

Official Title

Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2017 (Actual)

Primary Completion Date

June 6, 2024 (Anticipated)

Study Completion Date

December 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Benjamin CALVET

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Alzheimer's disease and related syndromes have become a major public health priority issue in France. Pharmacological treatments are ineffective and symptomatic, and only delay the progression of the disease. The management of Alzheimer's disease involves the development of multi-domain prevention programs, including physical activity and neurostimulation by cognitive stimulation. They aim to delay the appearance of fragility defined according to Fried by difficulties in walking, weight loss, fatigue, lack of wrist strength and sedentary lifestyle. Transcranial direct current stimulation (tDCS) is a stimulation technique using a low intensity DC electric current that acts by modulating neuronal excitability at the cerebral level. According to recent data, by its action on the cerebral cortex, this simple and non-invasive stimulation technique could prevent the effects of pathological aging, and reduce the cognitive difficulties of the elderly concerning episodic memory, attention and executive functions. These difficulties are also factors related to the risk of the elderly falling (defined by the slowness of walking speed, reduced monopodal support time and the existence of a falling antecedent). 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) on these criteria. This effect may stop or curb cognitive decline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

tDCS, cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

sham versus stimulation

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

sham stimulation

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

tDCS

Other Intervention Name(s)

transcranial direct current stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Murielle Girard, PhD

Phone

0033555431028

murielle.girard@ch-esquirol-limoges.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Calvet, MD, PhD

Organizational Affiliation

Centre Hospitalier Esquirol

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Esquirol

City

Limoges

ZIP/Postal Code

87025

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Murielle Girard

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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