A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blinded, Placebo Controlled Pilot Trial of the Feasibility of High Definition Transcranial Direct Current Stimulation and Cognitive Training in Patients With Mild Cognitive Impairment.

Conditions
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Mild Cognitive Impairment, Memory Disorders, Memory Loss

Intervention / Treatment
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* Device: HD-tDCS combined with CT
* Device: sham HD-tDCS combined with CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥50-90 years Right handed Willing and able to undergo all procedures Retains decisional capacity at initial visit Meets criteria for MCI, amnestic type (Petersen, 2004). Exclusion Criteria: Left handed patients 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HD-tDCS combined with CT<br>HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months | Device: HD-tDCS combined with CT<br>* HD-tDCS treatments will be administered during a cognitive training session.<br>|
| Sham Comparator: sham HD-tDCS combined with CT<br>sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months | Device: sham HD-tDCS combined with CT<br>* sham-HD-tDCS treatments will be administered during a cognitive training session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment completion rates | This pilot study would prove the feasibility of the proposed approach. Treatment completion rates of less than 75% could be reasonably excluded if all 8 patients are observed to complete the 6 month treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Recruiting and consenting 8 patients over a period of 3 months would support the feasibility of conducting a larger-scale, 2-site, phase II trial with 120 MCI patients over a span of 5 years (i.e. approximately 32 patients/year | 3 months |