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

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Device: transcranial direct current stimulation (tDCS)

• Registration Number: NCT04759092
• Lead Sponsor: University Hospital of North Norway

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-18
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with tDCS	transcranial direct current stimulation (tDCS)	Home based treatment with tDCS for four months

Primary Outcome Measures

Name	Time	Method
To investigate adverse effects of the treatment	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	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

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Troms, Norway