N/A
N=16
Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study
Mild Cognitive Impairment · Cognitive Impairment · Neurocognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03521089 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Flanker Inhibitory Control and Attention Test Scores — 35.1; 41.5 score on a scale — p=0.0039
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001 (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Flanker Inhibitory Control and Attention Test Scores |
35.1; 41.5 | 0.0039 sig |
| PRIMARY Change in Picture Vocabulary Test Scores |
52.0; 52.0 | 0.9674 |
| PRIMARY Change in List Sorting Working Memory Test Scores |
60.5; 51.8 | 0.0067 sig |
| PRIMARY Change in Dimensional Change Card Sort Test |
43.7; 48.0 | 0.3069 |
| PRIMARY Change in Pattern Comparison Processing Speed Test Scores |
46.6; 51.6 | 0.2609 |
| PRIMARY Change in Picture Sequence Memory Test v2.1 Score |
45.2; 42.8 | 0.6951 |
| PRIMARY Change in Oral Reading Recognition Test Score |
58.5; 56.1 | 0.3592 |
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.
Eligibility 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 ≤ 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)
Data sourced from ClinicalTrials.gov (NCT03521089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.