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Completed

NCT Number: NCT03325205

MR Guided tDCS in Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, University of Northern Norway

Tromsø, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alzheimer's Disease, mild and moderate stage

Exclusion criteria

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

Treatment and study plan

Anodal tDCS

Other

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 tDCS

Other

The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS

Primary outcomes

  1. Performance on Neuropsychological tests

    Time frame: 4 months

    Compare scores before and after tDCS stimulation

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • Helse Nord

Registry information

Official study title

MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2017
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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