A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
tDCS
1 other identifier
interventional
8
1 country
1
Brief Summary
The study is an open label study on patients with Alzheimer's dementia using home based transcranial direct current (tDCS) stimulation. Aims of the study is to investigate applicability and effect of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 28, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedOctober 11, 2021
October 1, 2021
2.1 years
January 28, 2021
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
To investigate adverse effects of the treatment
Investigation of tolerability of long term home based tDCS to patients with Alzheimer's by using the Adverse effect questionnaire for tDCS
4 months
To investigate effect of the treatment
Investigate possible change in cognitive tests (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Mini Mental Status Examination ( MMSE), Clock drawing test, Trail making test A \& B) after 4 months treatment and change 4 months after end of treatment
8 months
Study Arms (1)
Treatment with tDCS
EXPERIMENTALHome based treatment with tDCS for four months
Interventions
Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.
Eligibility Criteria
You may qualify if:
- Age 60-85.
- Fulfil diagnostic criteria of probable Alzheimer's dementia.
- Participants has to live with a caregiver.
You may not qualify if:
- Implant in head
- Seizure history
- Severe illness,
- Psychosis or depression measured with a cornell score over 11.
- Mini mental status (MMSE) score\<17.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of North Norwaylead
- University of Tromsocollaborator
Study Sites (1)
University Hospital of North Norway
Tromsø, Troms, 9091, Norway
Related Publications (1)
Gronli OK, Daae Rasmussen I, Aslaksen PM, Bystad M. A four-month home-based tDCS study on patients with Alzheimer's disease. Neurocase. 2022 Jun;28(3):276-282. doi: 10.1080/13554794.2022.2100710. Epub 2022 Jul 19.
PMID: 35852094DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole K Grønli Grønli, MD/PHD
University Hospital of North Norway
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD/phd senior consultant
Study Record Dates
First Submitted
January 28, 2021
First Posted
February 18, 2021
Study Start
April 1, 2019
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
October 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
No plan of sharing individual participant data, because its not a part of the approvement of the advisory board.