The primary objective of this project is to assess the feasibility of multi-field, extended HD-tDCS (MFE-HD-tDCS) with simultaneous computerized CT as a viable intervention to improve cognitive function in patients with MCI. This double-blinded, randomized pilot clinical trial of repetitive daily HD-tDCS/sham HD-tDCS, administered in combination with CT to subjects with MCI in 3 monthly blocks of 5 daily sessions for a total of 15 sessions will enroll 8 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
HD-tDCS treatments will be administered during a cognitive training session.
sham-HD-tDCS treatments will be administered during a cognitive training session.
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion
This measure assesses consent rates and treatment completion amongst subjects by assessing the number of subjects who signed consent forms and the number of completed study visits. In this study, 9 subjects provided informed consent. 1 subject was withdrawn. 8 subjects completed treatment. Therefore, only the data from the 8 subjects who completed treatment were analyzed.
Time frame: 6 months
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT
Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) is a composite of 4 measures with well-established sensitivity for the detection of cognitive decline in prodromal and mild dementia. It is calculated by summing the standardized z-scores of each of the following: * Rey Auditory Verbal Learning Test (0-48 points), Logical Memory IIa sub-test from the Wechsler Memory test (0-25 points) * Mini Mental Status Examination (0-30 points) * Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale-Revised (0-93 points) Z-score of 0 represents the sample mean. A Z-score of 0 indicates average cognitive performance compared to the reference group. For ADCS-PACC, more standard deviations above the mean generally represent a better outcome. There are not specific clinically relevant thresholds universally agreed upon for ADCS-PACC scores. Scores are typically used to compare changes over time.
Time frame: Alzheimer's Disease Cooperative Study, Preclinical Alzheimer's Cognitive Composite (ADCS-PACC) score at 3 and 6 months from baseline.
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI
Time frame: Measure quality of life in subjects over a period of 3 months
Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To report the correlation between activation in different brain regions reported. The clinical significance of increasing or reducing connectivity remains unclear. For example, increased connectivity could lead to strengthening of a hypo-functioning network, but reducing connectivity could also be the result of normalizing aberrant and/or compensatory hypo-connectivity. Calculation details: Pearson r correlation coefficients were computed and transformed to Fisher-z. Independent t-test or Wilcoxon Rank Sum analyses were conducted to investigate changes in connectivity from pre- to post-intervention between groups (Active versus Sham). Higher Z-scores (standard deviations above the mean) represent greater functional connectivity (stronger temporal synchronization) between the specified regions of interest (ROIs). Lower Z-scores represent reduced functional connectivity (weaker synchronization). A decrease in Z-scores (lower connectivity) is considered a better outcome.
Time frame: 3 months