Therapeutic Effect of Direct Current Stimulation on Cognitive Function of Mild to Moderate Alzheimer Patients
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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 |
- 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.
- 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:
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Eligibility| Ages Eligible for Study: | 45 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 May 16, 2013