MR Guided tDCS in Alzheimer's Disease

NCT ID: NCT03325205

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2020-03-10

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Anodal tDCS

Intervention Type: 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

Participants receive sham tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Nord

INDUSTRY

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per M Aslaksen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromso

Locations

Department of Psychology, University of Northern Norway

Tromsø, , Norway

Countries

Norway

References

Rasmussen ID, Boayue NM, Mittner M, Bystad M, Gronli OK, Vangberg TR, Csifcsak G, Aslaksen PM. High-Definition Transcranial Direct Current Stimulation Improves Delayed Memory in Alzheimer's Disease Patients: A Pilot Study Using Computational Modeling to Optimize Electrode Position. J Alzheimers Dis. 2021;83(2):753-769. doi: 10.3233/JAD-210378.

Reference Type: DERIVED

PMID: 34366347 (View on PubMed)

Other Identifiers

2017/794 (REK)

Identifier Type: -

Identifier Source: org_study_id