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

Alzheimer Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746498
• Other study ID #: Direct current in Alzheimer's
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: December 14, 2012
• Start date: June 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 79 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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
• 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 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

Locations

Country	Name	City	State
Egypt	Eman Khedr	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	base line and after 2 months	No
Secondary	changes in cortical excitability		Base line and after 10 days	No
Secondary	Wechsler memory scale		Basal and 2 months	No
Secondary	Intelligent questant ( IQ)		basal and 2 months	No