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Therapeutic Role of Transcranial DCS in Alzheimer

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Anodal tDCS

    sham group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change in measurement of improvement in cognitive function by using MMSE
    Change in measurement of improvement in cognitive function by using MMSE
    Change in measurement of improvement in cognitive function by cornell Scale
    Change in measurement of improvement in cognitive function by cornell Scale

    Secondary Outcome Measures

    The change of measurement of brain damage biomarkers modulation in plasma (i.e. Tau, Beta-Amyloid, Lipid Peroxidation) cornell Scale
    measure the change of brain damage biomarkers modulation in plasma (i.e. Tau, Beta-Amyloid, Lipid Peroxidation)

    Full Information

    First Posted
    October 14, 2017
    Last Updated
    October 17, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03313518
    Brief Title
    Therapeutic Role of Transcranial DCS in Alzheimer
    Official Title
    Therapeutic Role of Transcranial Direct Current Stimulation (tDCS) in Alzheimer Patients, Double Blind Placebo Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 12, 2016 (Actual)
    Primary Completion Date
    October 10, 2017 (Actual)
    Study Completion Date
    October 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anodal tDCS
    Arm Type
    Active Comparator
    Arm Description
    Transcranial Direct Current Stimulation using anodal electrode, 15 patients received real anodal tDCS 2mA for 20 minutes for 10 consecutive days.
    Arm Title
    sham group
    Arm Type
    Sham Comparator
    Arm Description
    Fifteen patients received sham anodal tDCS 2mA for 20 minutes for 10 consecutive days.
    Intervention Type
    Device
    Intervention Name(s)
    tDCS
    Intervention Description
    15 patients received real anodal tDCS for 20 minutes daily for 10 consecutive days.
    Intervention Type
    Device
    Intervention Name(s)
    Sham tDCS
    Intervention Description
    15 patients received sham anodal tDCS for 20 minutes daily for 10 consecutive days.
    Primary Outcome Measure Information:
    Title
    Change in measurement of improvement in cognitive function by using MMSE
    Description
    Change in measurement of improvement in cognitive function by using MMSE
    Time Frame
    three months
    Title
    Change in measurement of improvement in cognitive function by cornell Scale
    Description
    Change in measurement of improvement in cognitive function by cornell Scale
    Time Frame
    Three months
    Secondary Outcome Measure Information:
    Title
    The change of measurement of brain damage biomarkers modulation in plasma (i.e. Tau, Beta-Amyloid, Lipid Peroxidation) cornell Scale
    Description
    measure the change of brain damage biomarkers modulation in plasma (i.e. Tau, Beta-Amyloid, Lipid Peroxidation)
    Time Frame
    ten days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eman M. Khedr, MD
    Organizational Affiliation
    Professor of Neurology, Faculty of Medicine, Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30940012
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Therapeutic Role of Transcranial DCS in Alzheimer

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