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Therapeutic Role of Transcranial DCS in Alzheimer

NCT ID: NCT03313518

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-12

Study Completion Date

2017-10-10

Brief Summary

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The aim of this study is to evaluate the oxidative stress and brain damage biomarkers induced by tDCS in patients with AD and to assess the long term neurophysiological and behavioral effects after repeated daily tDCS sessions for 10 days. Thirty AD patients diagnosed according to 2011 McKhann criteria will be randomly assigned to receive 10 real anodal tDCS or sham at 2mA intensity for 20 minutes per session daily. All patients will be evaluated at baseline, at the end of the sessions and 1, 2, and 3 months later with neurophysiological and behavioral examination.

Detailed Description

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The aim of this study is to evaluate the oxidative stress and brain damage biomarkers induced by tDCS in patients with AD and to assess the long term neurophysiological and behavioral effects after repeated daily tDCS sessions for 10 days. Thirty AD patients diagnosed according to 2011 McKhann criteria will be randomly assigned to receive 10 real anodal tDCS or sham at 2mA intensity for 20 minutes per session daily. Patients were classified into two groups using closed envelope. One group will receive 10 sessions real tdcs and other group will receive sham tdcs.

The study will be a double-blind, placebo controlled, within subject, parallel design.

tDCS will be delivered bilaterally by a constant current electrical stimulator connected to a pair of sponge electrodes. The investigators will use a non-cephalic reference electrode for tDCS: stimulating electrode will be placed over the left temporo-parietal lobe for 20 minutes and then over the right temporoparietal lobe for another 20 minutes in AD patients, while the reference electrode will be placed over the right deltoid muscle. The stimulating current will be anodal DC at 2 mA intensity delivered for 20 minutes per session for 10 days. All patients will be evaluated at baseline, at the end of the treatment and 1 and 2,and 3months later with neuropsychological and behavioural examination.

Conditions

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Alzheimer Disease

Keywords

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tDCS, Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anodal tDCS

Transcranial Direct Current Stimulation using anodal electrode, 15 patients received real anodal tDCS 2mA for 20 minutes for 10 consecutive days.

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

15 patients received real anodal tDCS for 20 minutes daily for 10 consecutive days.

sham group

Fifteen patients received sham anodal tDCS 2mA for 20 minutes for 10 consecutive days.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

15 patients received sham anodal tDCS for 20 minutes daily for 10 consecutive days.

Interventions

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tDCS

15 patients received real anodal tDCS for 20 minutes daily for 10 consecutive days.

Intervention Type DEVICE

Sham tDCS

15 patients received sham anodal tDCS for 20 minutes daily for 10 consecutive days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All subject were diagnosed with Probable AD according to NINCDS/ADRDA Criteria for Alzheimer's Disease.
* Onset age \> 60.
* All 4 grandparents are of Ashkenazi Jewish origin as declared by the subject.
* Subject or subject's legal representative has signed the informed consent form.

Exclusion Criteria

* All subjects who were diagnosed with Possible AD according to NINCDS/ADRDA Criteria for Alzheimer's Disease.
* Subjects who were diagnosed with dementia due to other diseases, or with AD and contribution of other disorders (Mixed dementia):
* Brain CT/MRI suggesting alternative diagnoses, such as intracranial space occupying lesions, vascular lesion of the brain, white matter lesion, or hydrocephalus.
* Subjects who had known carrier of a blood transmitted infectious disease or suffers from conditions in which phlebotomy is contra-indicated.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Eman M. Khedr

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman M. Khedr, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology, Faculty of Medicine, Assiut University

References

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Khedr EM, Salama RH, Abdel Hameed M, Abo Elfetoh N, Seif P. Therapeutic Role of Transcranial Direct Current Stimulation in Alzheimer Disease Patients: Double-Blind, Placebo-Controlled Clinical Trial. Neurorehabil Neural Repair. 2019 May;33(5):384-394. doi: 10.1177/1545968319840285. Epub 2019 Apr 3.

Reference Type DERIVED
PMID: 30940012 (View on PubMed)

Other Identifiers

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tDCS in Alzheimer

Identifier Type: -

Identifier Source: org_study_id