Alzheimer DiseasetDCSNCT04759092
A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
A study testing transcranial direct current stimulation (tDCS) in people with Alzheimer Disease, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-85.
- Fulfil diagnostic criteria of probable Alzheimer's dementia.
- Participants has to live with a caregiver.
- If medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required.
Who cannot join
- Implant in head
- Seizure history
- Severe illness,
- Psychosis or depression measured with a cornell score over 11.
- Mini mental status (MMSE) score<17.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4 month period. Anodal electrode is placed over the left temporal lobe. Participants is followed up by home visit and phone calls.
Cognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.
- Conditions
- Alzheimer Disease
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
Also called tDCS
Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with tDCS | Experimental | Home based treatment with tDCS for four months Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Apr 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment study, open label
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Ole Kristian Grønli, University Hospital of North Norway
- Investigators
- Ole K Grønli Grønli, MD/PHD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759092
- Sponsor's protocol ID
- TDCS1HB
- Acronym
- tDCS
- Status last verified
- Oct 2021
- First submitted
- 28 Jan 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan of sharing individual participant data, because its not a part of the approvement of the advisory board.
Publications
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.
PubMed 35852094
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT04759092
- Acronym / sponsor ID
- tDCS / TDCS1HB
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4 month period. Anodal electrode is placed over the left temporal lobe. Participants is followed up by home visit and phone calls.
Cognitive tests are performed prior to the treatment period, right after finishing 4 months of treatment and 4 months after treatment is terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment study, open label
| Arm | Type | Receives |
|---|---|---|
| Treatment with tDCS | Experimental | Device: transcranial direct current stimulation (tDCS)Home based treatment with tDCS for four months |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60-85.
- Fulfil diagnostic criteria of probable Alzheimer's dementia.
- Participants has to live with a caregiver.
- If medicated with cholinesterase inhibitors or memantine, a stable dose the last three months before inclusion is required.
Key exclusion criteria (5 listed)
- Implant in head
- Seizure history
- Severe illness,
- Psychosis or depression measured with a cornell score over 11.
- Mini mental status (MMSE) score<17.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS)Also: tDCSApply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months. | Device | Treatment with tDCS |
Primary outcome
To investigate adverse effects of the treatment
Time frame: 4 months
Investigation of tolerability of long term home based tDCS to patients with Alzheimer's by using the Adverse effect questionnaire for tDCS
To investigate effect of the treatment
Time frame: 8 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 35852094Gronli 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.
- Individual participant dataSharing planned: No. No plan of sharing individual participant data, because its not a part of the approvement of the advisory board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole K Grønli Grønli, MD/PHD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Alzheimer Disease, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate adverse effects of the treatment (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.