- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03521089
Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study
Cathodal Transcranial Direct Current Stimulation (tDCS) in Mild Cognitive Impairment (MCI): A Randomized, Double-Blind, Sham-Controlled Pilot Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 ≤ 16 which signifies no 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Flanker Inhibitory Control and Attention Test Scores
Time Frame: Baseline, 1-month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1-month post intervention
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Change in Picture Vocabulary Test Scores
Time Frame: Baseline, 1 month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1 month post intervention
|
Change in List Sorting Working Memory Test Scores
Time Frame: Baseline, 1 month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1 month post intervention
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Change in Dimensional Change Card Sort Test
Time Frame: Baseline, 1 month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1 month post intervention
|
Change in Pattern Comparison Processing Speed Test Scores
Time Frame: Baseline, 1 month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1 month post intervention
|
Change in Picture Sequence Memory Test v2.1 Score
Time Frame: Baseline, 1 month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1 month post intervention
|
Change in Oral Reading Recognition Test Score
Time Frame: Baseline, 1 month post intervention
|
Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test.
The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance.
The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.
|
Baseline, 1 month post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yonas E Geda, MD, MSc, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-007478
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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