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

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Procedure: Direct current stimulation using Anodal electrode; Procedure: direct current stimulation using cathodal electrode; Procedure: Sham direct current stimulation

• Registration Number: NCT01746498
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-30
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Direct current stimulation using Anodal electrode	11 patients We Applied real anodal tDCS on the left dorsolateral prefrontal cortex (DLPFC)20 minutes every day for 10 consecutive days.
Group 2	direct current stimulation using cathodal electrode	11 patients we applied cathodal tDCS on left DLPFC for 20 minutes every day for 10 consecutive days.
Group 3	Sham direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Minimental state Examination	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.

Secondary Outcome Measures

Name	Time	Method
changes in cortical excitability	Base line and after 10 days
Wechsler memory scale	Basal and 2 months
Intelligent questant ( IQ)	basal and 2 months

Trial Locations

Locations (1)

Eman Khedr; 🇪🇬 Assiut, Egypt