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