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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04759092
Acronym
tDCS
Enrollment
8
Registered
2021-02-18
Start date
2019-04-01
Completion date
2021-05-01
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

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.

Interventions

DEVICEtranscranial direct current stimulation (tDCS)

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

Sponsors

University of Tromso
CollaboratorOTHER
University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Treatment study, open label

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To investigate adverse effects of the treatment4 monthsInvestigation 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 treatment8 monthsInvestigate 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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026