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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eman M. Khedr, Assiut University
ClinicalTrials.gov Identifier:
NCT01746498
First received: November 30, 2012
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Alzheimer Disease
Procedure: Direct current stimulation using Anodal electrode
Procedure: direct current stimulation using cathodal electrode
Procedure: Sham direct current stimulation

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

Resource links provided by NLM:


Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Minimental state Examination [ Time Frame: base line and after 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Base line and after 10 days ] [ Designated as safety issue: No ]
  • Wechsler memory scale [ Time Frame: Basal and 2 months ] [ Designated as safety issue: No ]
  • Intelligent questant ( IQ) [ Time Frame: basal and 2 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   45 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746498

Locations
Egypt
Eman Khedr
Assiut, Egypt, 11517
Sponsors and Collaborators
Assiut University
  More Information

No publications provided

Responsible Party: Eman M. Khedr, Professor, Assiut University
ClinicalTrials.gov Identifier: NCT01746498     History of Changes
Other Study ID Numbers: Direct current in Alzheimer's
Study First Received: November 30, 2012
Last Updated: December 14, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Assiut University:
Alzheimer disease
Direct current stimulation
cognitive function
memory

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014