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

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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

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.

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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


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




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



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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.

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
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Contact: Ole Kristian Grønli, MD/PHD +4791713535 ole.gronli@unn.no

Locations
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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
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Principal Investigator: Ole K Grønli Grønli, MD/PHD University Hospital of North Norway
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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.

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