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Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease (tDCS)

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ClinicalTrials.gov Identifier: NCT02518412
Recruitment Status : Unknown
Verified August 2015 by University of Tromso.
Recruitment status was:  Recruiting
First Posted : August 7, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
University of Tromso

Brief Summary:

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a cognitive enhancer for patients with Alzheimer disease.

Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are applied to the brain by using two electrodes. These electrodes are placed on the scalp. The current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the present study, participants will undergo six stimulations. The effect of all stimulations swill be measured with neuropsychological testing before the first (pre) and after the sixth tDCS stimulation (post).


Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: tDCS Other: Placebo tDCS Not Applicable

Detailed Description:
The present study is a randomized controlled study (RCT) and will use tDCS to stimulate left temporal lobe and hopefully improve verbal memory functions. A total of 30 patients with Alzheimer disease will receive tDCS treatment for 30 minutes, six times. Half of the patients will undergo sham stimulation. These six stimulations will be executed during 10 days. Patients will be tested with neuropsychological tests before the first stimulation and after the last stimulation to assess the effect of the treatment. Patients will be retested six months later in order to investigate long-term effects ot the stimulation. The main hypothesis in the present study is that tDCS stimulation will lead to significant improvements in verbal memory functions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) as a Cognitive Enhancer for Patients With Alzheimers Disease
Study Start Date : May 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Participants receive active tDCS stimulation. Half of the participants receive active tDCS stimulation, i.e 30 minutes active stimulation of the temporal cortex.
Other: tDCS
Transcranial Direct Current Stimulation (tDCS) is a non-invasive treatment method, using a low Direct current stimulation to increase excitability and thus stimulate plasticity and cognitive functions.

Placebo Comparator: Placebo tDCS
Participants receive placebo tDCS stimulation. Half of the participants receive placebo tDCS stimulation, i.e 30 minutes inactive stimulation of the temporal cortex.
Other: Placebo tDCS
Half of the patients will receive Placebo tDCS. The procedure is the same as for active tDCS, but the in the Placebo tDCS the stimulation is non-active / sham.




Primary Outcome Measures :
  1. Neuropsychological testing [ Time Frame: Changes in results from neuropsychological testing pre (before the first stimulation) og post treatment (after the last stimulation). There will be a ten days time frame from pre-test to post-test. ]
    We will use a neuropsychological test called California Verbal Learning Test and test verbal memory functions before the first treatment session and after the last treatment session. We will use this test to assess how the tDCS intervention will affect verbal memory functions. There will be a maximum of ten days between pre and post testing, since the entire stimulation procedure (six stimulations) will be executed during ten days.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alzheimers disease according to (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association).
  • The cognitive impairment and decline must be documented by cognitive / neuropsychological testing and from an informant.

Exclusion Criteria:

  • Stroke,
  • Cancer,
  • Psychiatric disorders (major depression, psychosis) or diseases / injuries in the central nervous system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518412


Contacts
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Contact: Per M Aslaksen, PhD 0047776 49234
Contact: Martin K Bystad, Cand.psychol 0047760809

Locations
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Norway
Department of Psychology, University of Tromsø Recruiting
Tromsø, Norway, N-9037
Contact: Per M Aslaksen, PhD    004777649234      
Contact: Martin K Bystad, Cand.Psychol    004777620809      
Sponsors and Collaborators
University of Tromso
Investigators
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Study Director: Per M Aslaksen, PhD University of Tromso
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02518412    
Other Study ID Numbers: 2012/1890(REK)
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by University of Tromso:
Alzheimers disease
Transcranial direct current stimulation (tDCS)
Neuromodulation
Neuropsychology
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders