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

Alzheimer Disease Clinical Trial

— tDCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759092
• Other study ID #: TDCS1HB
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: October 2021
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Troms

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months
Primary	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	8 months