Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759092
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Ole Kristian Grønli, University Hospital of North Norway

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: transcranial direct current stimulation (tDCS) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment study, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment with tDCS
Home based treatment with tDCS for four months
 Device: transcranial direct current stimulation (tDCS)
Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.
Other Name: tDCS


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To investigate tolerability [ 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759092


Contacts
Layout table for location contacts
Contact: Ole Kristian Grønli, MD/PHD +4791713535 ole.gronli@unn.no

Locations
Layout table for location information
Norway
University Hospital of North Norway Recruiting
Tromsø, Troms, Norway, 9091
Contact: Ole Kristian Grønli, MD/Phd    +4777627793    ole.k.gronli@unn.no   
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
Investigators
Layout table for investigator information
Principal Investigator: Ole K Grønli Grønli, MD/PHD University Hospital of North Norway
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ole Kristian Grønli, MD/phd senior consultant, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT04759092    
Other Study ID Numbers: TDCS1HB
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan of sharing individual participant data, because its not a part of the approvement of the advisory board.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders