Memory Disorders, Memory Loss, Mild Cognitive Impairment
Conditions
Brief summary
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.
Interventions
DEVICEHD-tDCS combined with CT
HD-tDCS treatments will be administered during a cognitive training session.
DEVICEsham HD-tDCS combined with CT
sham-HD-tDCS treatments will be administered during a cognitive training session.
Sponsors
Medical College of Wisconsin
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blinded
Intervention model description
placebo controlled
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥50-90 years 2. Willing and able to undergo all procedures 3. Retains decisional capacity at initial visit 4. Meets criteria for MCI, amnestic type (Petersen, 2004).
Exclusion criteria
1. Significant kidney injury requiring hemodialysis 2. Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker 3. Significant congestive heart failure 4. History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms 5. History of thalamic lacunar stroke 6. Modified Hachinski Ischemia Score \>4 points 7. History of seizure disorder requiring medication 8. History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor) 9. History of HIV/AIDS 10. Severe untreated obstructive sleep apnea 11. Greater than three servings alcohol daily or illicit drug use 12. Major neurologic disorders other than dementia (e.g., MS, ALS) 13. Schizophrenia, bipolar disorder, other serious mental illnesses 14. Other significant medical conditions at investigators' discretion 15. Pregnancy 16. Lack of study partner (Participants are allowed to find a new study partner if the original study partner withdraws)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT | Alzheimer's Disease Cooperative Study, Preclinical Alzheimer's Cognitive Composite (ADCS-PACC) score at 3 and 6 months from baseline. | 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. |
| Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI | 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 | 3 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
1 subject signed the consent form and withdrew prior to being assigned to one of the treatment arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 | 1 / 4 |
Outcome results
None listed