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Therapeutic Effect of Direct Current Stimulation on Cognitive Function of Mild to Moderate Alzheimer Patients

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Direct current stimulation using Anodal electrode
direct current stimulation using cathodal electrode
Sham direct current stimulation
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 Alzheimer disease, Direct current stimulation, cognitive function, memory

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thirty patients with a diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA) (McKhann G et al.,1994) will be included in this study.

Exclusion Criteria:

  • previous history of stroke
  • Metabolic disturbances
  • Other major medical illness or epilepsy
  • Patients metallic objects in the body
  • Patients subjected to a craniotomy in the past.

Sites / Locations

  • Eman Khedr

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

11 patients We Applied real anodal tDCS on the left dorsolateral prefrontal cortex (DLPFC)20 minutes every day for 10 consecutive days.

11 patients we applied cathodal tDCS on left DLPFC for 20 minutes every day for 10 consecutive days.

11 patients We applied sham stimulations(anodal tDCS) on the left DLPFC for few seconds the stop stimulations 2 mA every day for 10 days.

Outcomes

Primary Outcome Measures

Minimental state Examination
To measure the cognitive function in alzheimer patients through measuring orientation, Registration, Attention and calculation, Recall,language, and copying with a total score 30.

Secondary Outcome Measures

changes in cortical excitability
Wechsler memory scale
Intelligent questant ( IQ)

Full Information

First Posted
November 30, 2012
Last Updated
December 14, 2012
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT01746498
Brief Title
Therapeutic Effect of Direct Current Stimulation on Cognitive Function of Mild to Moderate Alzheimer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study is planed to compare the efficacy of real (anodal and cathodal) vs sham transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex (DLPFC) on cognitive functions and cortical excitability of patients with Alzheimer disease (AD). Thirty three with mild to moderate Alzheimer's disease (AD) patients (diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders and Stroke Alzheimer Disease and Related Disorders Association [NINCDS-ADRDA] were included in this study) were randomly classified into one of three groups (eleven for each group). The first group received anodal tDCS over left DLPFC and 2rd group received cathodal tDCS on the left DLPFC and the 3rd group received sham tDCS stimulation, daily for 10 consecutive days (5 days/week for 2 weeks). Minimental State Examination (MMSE), psychometric assessment for cognitive functions (MMSE, Wechsler memory scale, Wechsler adult Intelligent scale) were assessed before, after 10th sessions, and then after 1 and 2 month. Cortical excitability was assessed in both hemispheres before and after the end of sessions. Neurophysiological evaluations included resting and active motor threshold (rMT and aMT), and cortical silent period (CSP). At the time of recruitment, none of the patients taking antidepressants, or neuroleptic, sedative-hypnotic drugs for at least two weeks before the assessment. All participants or their caregivers will give informed consent before participation in the test and after full explanation of the study protocol. Outcome: The real group received (anodal and cathodal) tDCS are expected to have more improvement on cognitive functions compared to sham tDCS group. tDCS is considered new adjuvant non pharmacological therapeutic tool for management of AD patients with mild to moderate degree dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer disease, Direct current stimulation, cognitive function, memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
11 patients We Applied real anodal tDCS on the left dorsolateral prefrontal cortex (DLPFC)20 minutes every day for 10 consecutive days.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
11 patients we applied cathodal tDCS on left DLPFC for 20 minutes every day for 10 consecutive days.
Arm Title
Group 3
Arm Type
Sham Comparator
Arm Description
11 patients We applied sham stimulations(anodal tDCS) on the left DLPFC for few seconds the stop stimulations 2 mA every day for 10 days.
Intervention Type
Procedure
Intervention Name(s)
Direct current stimulation using Anodal electrode
Intervention Description
11 patients who received real anodal tDCS on the left DLPFC, 2 mA for 20 minute every day for 10 consecutive days
Intervention Type
Procedure
Intervention Name(s)
direct current stimulation using cathodal electrode
Intervention Description
11 patients who received real cathodal tDCS on the left DLPFC, 2 mA for 20 minute every day for 10 consecutive days
Intervention Type
Procedure
Intervention Name(s)
Sham direct current stimulation
Other Intervention Name(s)
Direct current stimualtion (CX - 6650 Model TRCU - 04A Rolf Schneider Electronics, D-37130 Gleichen,, Germany).
Intervention Description
11 patients who received sham anodal tDCS on the left DLPFC just for few seconds, 2 ma, every day for 10 consecutive days
Primary Outcome Measure Information:
Title
Minimental state Examination
Description
To measure the cognitive function in alzheimer patients through measuring orientation, Registration, Attention and calculation, Recall,language, and copying with a total score 30.
Time Frame
base line and after 2 months
Secondary Outcome Measure Information:
Title
changes in cortical excitability
Time Frame
Base line and after 10 days
Title
Wechsler memory scale
Time Frame
Basal and 2 months
Title
Intelligent questant ( IQ)
Time Frame
basal and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thirty patients with a diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA) (McKhann G et al.,1994) will be included in this study. Exclusion Criteria: previous history of stroke Metabolic disturbances Other major medical illness or epilepsy Patients metallic objects in the body Patients subjected to a craniotomy in the past.
Facility Information:
Facility Name
Eman Khedr
City
Assiut
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

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Therapeutic Effect of Direct Current Stimulation on Cognitive Function of Mild to Moderate Alzheimer Patients

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