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
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
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
NCT ID
NCT03325205
First Posted
September 4, 2017
Last Updated
January 13, 2021
Sponsor
University of Tromso
Collaborators
Helse Nord
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
Learn more about this trial
MR Guided tDCS in Alzheimer's Disease
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