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Trial record 6 of 59 for:    soterix

Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study

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ClinicalTrials.gov Identifier: NCT03521089
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yonas E Geda, Mayo Clinic

Brief Summary:
This study evaluates the application of non-invasive brain stimulation in the treatment of Mild Cognitive Impairment (MCI) in adults aged 55-85. Half of the participants will receive transcranial direct current stimulation (tDCS), while the other half will receive sham (like placebo) stimulation.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Cognitive Impairment Neurocognitive Dysfunction Device: Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001 Not Applicable

Detailed Description:

The purpose of this study is to investigate whether giving transcranial direct current stimulation (tDCS) treatment using an investigational device called the Soterix tES Device (tDCS device) on the right side of the brain can improve performance on cognitive tests. Investigational means that the tDCS device is not approved by the U.S. Food and Drug Administration (FDA) for the use in this study.

tDCS is a non-invasive way to electrically stimulate the brain. The tDCS device is portable and runs on two 9-volt batteries. Electrodes from the tDCS device carry weak electrical current through the scalp and skull and into the brain. When the direction of the electric current flow is called cathodal, the brain under the site of stimulation reduces its activity.

When tasks are performed, certain parts of the brain are activated. Research studies have shown that younger adults and older adults activate similar parts of the brain when performing the same task (a memory task, for example). However, other researchers found older adults who scored worse on memory tasks, and those with Mild Cognitive Impairment, activated an additional part of the brain so both sides of the brain are activated. Researchers are not sure whether this additional activation is helpful or not. Investigators in this study believe that this extra activation may be contributing to worse performance on tasks.

It may be possible to use tDCS to reduce the brain activity on the extra activation (right) side in older adults, to resemble an activation pattern seen in younger adults (or higher scoring cohort). Using cathodal tDCS to reduce brain activity might help the brain in performing tasks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1 to active or sham transcranial direct current stimulation (tDCS) intervention
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Cathodal Transcranial Direct Current Stimulation (tDCS) in Mild Cognitive Impairment (MCI): A Randomized, Double-Blind, Sham-Controlled Pilot Study
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: Active tDCS
Active tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The active tDCS intervention include stimulation for 15 minutes at 1mA. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
Device: Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001
Transcranial direct current stimulation works by sending constant, low direct current through the electrodes. When these electrodes are placed in the region of interest, the current induces intracerebral current flow. This current flow then either increases or decreases the neuronal excitability in the specific area being stimulated based on which type of stimulation is being used. This change of neuronal excitability leads to alteration of brain function, which can be used in various therapies as well as to provide more information about the functioning of the human brain.
Other Names:
  • Soterix tDCS
  • Transcranial direct current stimulation
  • Non-invasive brain stimulation
  • Cathodal tDCS

Sham Comparator: Sham tDCS
Sham tDCS uses the Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001. The sham tDCS intervention lasts for 15 minutes. The cathode electrode will be placed over the right dorsolateral prefrontal cortex with reference electrode (anode) over the left dorsolateral prefrontal cortex. Both electrodes are covered by saline-soaked sponges that are held against the scalp by a pair of large, adjustable head straps. Treatment sessions will last for 15 minutes. 5 consecutive treatment sessions will be completed within 1 week.
Device: Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001
Transcranial direct current stimulation works by sending constant, low direct current through the electrodes. When these electrodes are placed in the region of interest, the current induces intracerebral current flow. This current flow then either increases or decreases the neuronal excitability in the specific area being stimulated based on which type of stimulation is being used. This change of neuronal excitability leads to alteration of brain function, which can be used in various therapies as well as to provide more information about the functioning of the human brain.
Other Names:
  • Soterix tDCS
  • Transcranial direct current stimulation
  • Non-invasive brain stimulation
  • Cathodal tDCS




Primary Outcome Measures :
  1. NIH Toolbox Cognition Battery: Flanker Inhibitory Control and Attention Test [ Time Frame: 1-month post intervention compared to baseline performance ]
    Cognitive outcome measurement



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients with confirmed MCI diagnosis
  • Age 55-85
  • Right handed (tested using the Edinburgh handedness inventory)
  • Total PHQ-8 of ≤ 9 which signifies no moderate or severe depression
  • All participants and/or caregivers must be able to provide informed consent

Exclusion Criteria:

  • Neurodegenerative disease (e.g. Parkinson's, Huntington's, Multiple Sclerosis) other than MCI
  • Previous brain lesion
  • Intracranial abnormality such as prior stroke
  • History of seizure disorder or epilepsy
  • A "true" positive response, after patient clarification, to any question on the modified TMS/tDCS Adult Safety Screen questionnaire that would impact patient safety
  • Any history of brain stimulation treatment (e.g., electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagal nerve therapy (VNS), deep brain stimulation (DBS))
  • Use of any investigational drug within 4 weeks
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines; acute or unstable cardiac disease; intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (exception: mouth/dental work) that cannot be safely removed
  • Known or suspected pregnancy (extremely unlikely as the age range for this study is 55-85 years)

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): NCT03521089


Contacts
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Contact: Stefanie Velgos 480-301-6934 velgos.stefanie@mayo.edu
Contact: Alicia Rankin 480-342-1258 rankin.alicia@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Stefanie Velgos    480-301-6934    velgos.stefanie@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Yonas E Geda, MD, MSc Mayo Clinic

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Responsible Party: Yonas E Geda, Professor of Neurology and Psychiatry, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03521089     History of Changes
Other Study ID Numbers: 16-007478
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Yonas E Geda, Mayo Clinic:
Mild Cognitive Impairment (MCI)
Transcranial Direct Current Stimulation (tDCS)

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders