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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

transcranial direct current stimulation (tDCS)

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital of North Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with tDCS

Arm Description

Home based treatment with tDCS for four months

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04759092

First Posted

January 28, 2021

Last Updated

October 4, 2021

Sponsor

University Hospital of North Norway

Collaborators

University of Tromso

1. Study Identification

Unique Protocol Identification Number

NCT04759092

Brief Title

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

Acronym

tDCS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

May 1, 2021 (Actual)

Study Completion Date

May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of North Norway

Collaborators

University of Tromso

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Treatment study, open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with tDCS

Arm Type

Experimental

Arm Description

Home based treatment with tDCS for four months

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation (tDCS)

Other Intervention Name(s)

tDCS

Intervention Description

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

Primary Outcome Measure Information:

Title

To investigate adverse effects of the treatment

Description

Investigation of tolerability of long term home based tDCS to patients with Alzheimer's by using the Adverse effect questionnaire for tDCS

Time Frame

4 months

Title

To investigate effect of the treatment

Description

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole K Grønli Grønli, MD/PHD

Organizational Affiliation

University Hospital of North Norway

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of North Norway

City

Tromsø

State/Province

Troms

ZIP/Postal Code

9091

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan of sharing individual participant data, because its not a part of the approvement of the advisory board.

Citations:

PubMed Identifier

35852094

Citation

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.

Results Reference

derived

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

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