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Completed

NCT Number: NCT04759092

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Troms, 9091, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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

Other names: tDCS

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • University of Tromso

Registry information

Acronym: tDCS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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