N/A
Completed N=8
A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
Mild Cognitive Impairment · Memory Disorders · Memory Loss
Source: ClinicalTrials.gov NCT04246164 ↗
Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Jan 2026
Primary outcomePrimary: Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion — 4; 4; 4; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion |
4; 4; 4; 4 | — |
| SECONDARY Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT |
-0.95975; 0.85375; -0.795; 1.596; -0.38575; 1.227 | — |
| SECONDARY Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI |
0; 0 | — |
| SECONDARY Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity |
-0.09065; 0.12688; -0.0989; 0.11118 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥50-90 years
- Willing and able to undergo all procedures
- Retains decisional capacity at initial visit
- Meets criteria for MCI, amnestic type (Petersen, 2004).
Exclusion Criteria
- Significant kidney injury requiring hemodialysis
- Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
- Significant congestive heart failure
- History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
- History of thalamic lacunar stroke
- Modified Hachinski Ischemia Score >4 points
- History of seizure disorder requiring medication
- History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
- History of HIV/AIDS
- Severe untreated obstructive sleep apnea
- Greater than three servings alcohol daily or illicit drug use
- Major neurologic disorders other than dementia (e.g., MS, ALS)
- Schizophrenia, bipolar disorder, other serious mental illnesses
- Other significant medical conditions at investigators' discretion
- Pregnancy
- Lack of study partner (Participants are allowed to find a new study partner if the original study partner withdraws)
Data sourced from ClinicalTrials.gov (NCT04246164). 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. Informational only — not medical advice.