Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study
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| ClinicalTrials.gov Identifier: NCT03521089 |
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Recruitment Status :
Recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
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| 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 |
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.
| 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 : | February 2019 |
| Estimated Study Completion Date : | February 2019 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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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:
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- NIH Toolbox Cognition Battery: Flanker Inhibitory Control and Attention Test [ Time Frame: 1-month post intervention compared to baseline performance ]Cognitive outcome measurement
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.
| Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
| Contact: Stefanie Velgos | 480-301-6934 | velgos.stefanie@mayo.edu | |
| Contact: Alicia Rankin | 480-342-1258 | rankin.alicia@mayo.edu |
| United States, Arizona | |
| Mayo Clinic in Arizona | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Stefanie Velgos 480-301-6934 velgos.stefanie@mayo.edu | |
| Principal Investigator: | Yonas E Geda, MD, MSc | Mayo Clinic |
| 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: | May 10, 2018 |
| Last Verified: | May 2018 |
| 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:
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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 |