A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.

NCT ID: NCT04759092

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-05-01

Brief Summary

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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

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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

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Treatment study, open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with tDCS

Home based treatment with tDCS for four months

Group Type EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.

Interventions

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transcranial direct current stimulation (tDCS)

Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Implant in head
* Seizure history
* Severe illness,
* Psychosis or depression measured with a cornell score over 11.
* Mini mental status (MMSE) score\<17.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tromso

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Ole Kristian Grønli

MD/phd senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ole K Grønli Grønli, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Locations

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University Hospital of North Norway

Tromsø, Troms, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35852094 (View on PubMed)

Other Identifiers

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TDCS1HB

Identifier Type: -

Identifier Source: org_study_id

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