MR Guided tDCS in Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Other: Anodal tDCS; Other: Sham tDCS

• Registration Number: NCT03325205
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-08-22
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-30
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Alzheimer's Disease, mild and moderate stage

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Anodal 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 tDCS	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.

Primary Outcome Measures

Name	Time	Method
Performance on Neuropsychological tests	4 months	Compare scores before and after tDCS stimulation

Secondary Outcome Measures

Name	Time	Method
Hippocampal volume	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.

Trial Locations

Locations (1)

Department of Psychology, University of Northern Norway; 🇳🇴 Tromsø, Norway