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

Medical College of Wisconsin

Status: Completed

Conditions: Memory Disorders; Mild Cognitive Impairment; Memory Loss

Treatments: Device: sham HD-tDCS combined with CT; Device: HD-tDCS combined with CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04246164

PRO00035757

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups

HD-tDCS combined with CT

Active Comparator group

Description:

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

Treatment:

Device: HD-tDCS combined with CT

sham HD-tDCS combined with CT

Sham Comparator group

Description:

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

Treatment:

Device: sham HD-tDCS combined with CT