MR Guided tDCS in Alzheimer's Disease

NCT03325205 | Completed

• 1 other identifier: 2017/794 (REK)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Transcranial direct current stimulation; Neuromodulation; Individualizing brain stimulation; Neuropsychology

Outcome Measures

Primary Outcomes (1)

• Performance on Neuropsychological tests

  Compare scores before and after tDCS stimulation

  4 months

Secondary Outcomes (1)

• Hippocampal volume

  4 months

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Other: Anodal tDCS

Sham tDCS

SHAM COMPARATOR

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

Other: Sham tDCS

Interventions

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.

Active tDCS

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

Sham tDCS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alzheimer's Disease, mild and moderate stage

You may not qualify if:

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

Sponsors & Collaborators

• University of Tromso: lead
• Helse Nord: collaborator

Study Sites (1)

Department of Psychology, University of Northern Norway

Tromsø, Norway

Location

Related Publications (1)

• 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.

  PMID: 34366347 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Per M Aslaksen, Professor

  University of Tromso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: October 30, 2017
• Study Start: August 22, 2017
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)