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MR Guided tDCS in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03325205
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Helse Nord
Information provided by (Responsible Party):
University of Tromso

Brief Summary:
The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp. Electrode placement is individualized for each participant. Participants will undergo 15 stimulations, with a duration of 20 minutes each. All patients will undergo neuropsychological assessment and MRI evaluation.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Anodal tDCS Other: Sham tDCS Not Applicable

Detailed Description:
The project will be run as a Randomized Controlled Trial (RCT), where patients will be randomized to receive either active anodal tDCS or sham tDCS. The performance on neuropsychological tests will be the primary outcome variables in the present project. In addition, whole brain MRI volume measures will be used to measure specific effects of tDCS treatment. Electrode placement is individualized for each participant with brain modeling techniques.

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: MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Participants receive anodal tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.
Other: Anodal tDCS
Anodal Transcranial direct current stimulation (tDCS) is a non- invasive brain stimulation technique. Low intensity current (1-2 mA) is induced to increase excitability, stimulate plasticity and enhance cognitive functions.

Sham Comparator: Sham tDCS
Participants receive sham tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.
Other: Sham tDCS
The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS




Primary Outcome Measures :
  1. Performance on Neuropsychological tests [ Time Frame: 4 months ]
    Compare scores before and after tDCS stimulation


Secondary Outcome Measures :
  1. Hippocampal volume [ Time Frame: 4 months ]
    Compare performance on neuropsychological tests to hippocampal volume. Here we are looking at correlations between hippocampal thickness, performance on neuropsychological tests and effect of tDCS.



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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:

  • Alzheimer's Disease, mild and moderate stage

Exclusion Criteria:

  • Other neurological diseases or injuries
  • Stroke
  • Cancer
  • Psychiatric disorders (moderate/ severe depression, psychosis)

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): NCT03325205


Contacts
Contact: Ingrid D. Rasmussen, Cand.psychol 004777620809 ingrid.d.rasmussen@uit.no

Locations
Norway
Department of Psychology, University of Northern Norway Recruiting
Tromsø, Norway
Contact: Per M. Aslaksen, Professor    004777649234    per.m.aslaksen@uit.no   
Contact: Ingrid D. Rasmussen, Cand.psych.    004777620809    ingrid.d.rasmussen@uit.no   
Sponsors and Collaborators
University of Tromso
Helse Nord
Investigators
Principal Investigator: Per M Aslaksen, Professor University of Tromso

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT03325205     History of Changes
Other Study ID Numbers: 2017/794 (REK)
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Tromso:
Transcranial direct current stimulation
Neuromodulation
Individualizing brain stimulation
Neuropsychology

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders