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MR Guided tDCS in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Anodal tDCS
Sham tDCS
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Transcranial direct current stimulation, Neuromodulation, Individualizing brain stimulation, Neuropsychology

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Alzheimer's Disease, mild and moderate stage

Exclusion Criteria:

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

Sites / Locations

  • Department of Psychology, University of Northern Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Performance on Neuropsychological tests
Compare scores before and after tDCS stimulation

Secondary Outcome Measures

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.

Full Information

First Posted
September 4, 2017
Last Updated
January 13, 2021
Sponsor
University of Tromso
Collaborators
Helse Nord
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1. Study Identification

Unique Protocol Identification Number
NCT03325205
Brief Title
MR Guided tDCS in Alzheimer's Disease
Official Title
MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
Collaborators
Helse Nord

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Transcranial direct current stimulation, Neuromodulation, Individualizing brain stimulation, Neuropsychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Participants receive anodal tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Participants receive sham tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.
Intervention Type
Other
Intervention Name(s)
Anodal tDCS
Intervention Description
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
Intervention Name(s)
Sham tDCS
Intervention Description
The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS
Primary Outcome Measure Information:
Title
Performance on Neuropsychological tests
Description
Compare scores before and after tDCS stimulation
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Hippocampal volume
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per M Aslaksen, Professor
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, University of Northern Norway
City
Tromsø
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34366347
Citation
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.
Results Reference
derived

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MR Guided tDCS in Alzheimer's Disease

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