MR Guided tDCS in Alzheimer’s Disease

Overview

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.

Full Title of Study: “MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2019

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.

Interventions

  • 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.
  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Performance on Neuropsychological tests
    • Time Frame: 4 months
    • Compare scores before and after tDCS stimulation

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Alzheimer's Disease, mild and moderate stage

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Tromso
  • Collaborator
    • Helse Nord
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Per M Aslaksen, Professor, Principal Investigator, University of Tromso
  • Overall Contact(s)
    • Ingrid D. Rasmussen, Cand.psychol, 004777620809, ingrid.d.rasmussen@uit.no

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