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

December 14, 2012 updated by: Eman M. Khedr, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 11517
        • Eman Khedr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
11 patients We Applied real anodal tDCS on the left dorsolateral prefrontal cortex (DLPFC)20 minutes every day for 10 consecutive days.
Procedure: Direct current stimulation using Anodal electrode
11 patients who received real anodal tDCS on the left DLPFC, 2 mA for 20 minute every day for 10 consecutive days
Active Comparator: Group 2
11 patients we applied cathodal tDCS on left DLPFC for 20 minutes every day for 10 consecutive days.
Procedure: direct current stimulation using cathodal electrode
11 patients who received real cathodal tDCS on the left DLPFC, 2 mA for 20 minute every day for 10 consecutive days
Sham Comparator: Group 3
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.
Procedure: Sham direct current stimulation
11 patients who received sham anodal tDCS on the left DLPFC just for few seconds, 2 ma, every day for 10 consecutive days
Other Names:
  • Direct current stimualtion (CX - 6650 Model TRCU - 04A Rolf Schneider Electronics, D-37130 Gleichen,
  • Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimental state Examination
Time Frame: base line and after 2 months
To measure the cognitive function in alzheimer patients through measuring orientation, Registration, Attention and calculation, Recall,language, and copying with a total score 30.
base line and after 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in cortical excitability
Time Frame: Base line and after 10 days
Base line and after 10 days
Wechsler memory scale
Time Frame: Basal and 2 months
Basal and 2 months
Intelligent questant ( IQ)
Time Frame: basal and 2 months
basal and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Direct current in Alzheimer's

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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