MR Guided tDCS in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325205
• Other study ID #: 2017/794 (REK)
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: January 2021
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Alzheimer's Disease, mild and moderate stage

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Norway	Department of Psychology, University of Northern Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
University of Tromso	Helse Nord

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on Neuropsychological tests	Compare scores before and after tDCS stimulation	4 months
Secondary	Hippocampal volume	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.	4 months