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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Memory Disorders; Memory Loss
• Interventions: Device: sham HD-tDCS combined with CT; Device: HD-tDCS combined with CT

• Registration Number: NCT04246164
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Study Start: 2021-01-25
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Age ≥50-90 years
2. Right handed
3. Willing and able to undergo all procedures
4. Retains decisional capacity at initial visit
5. Meets criteria for MCI, amnestic type (Petersen, 2004).

Exclusion Criteria

1. Left handed patients
2. Significant kidney injury requiring hemodialysis
3. Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
4. Significant congestive heart failure
5. History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
6. History of thalamic lacunar stroke
7. Modified Hachinski Ischemia Score >4 points
8. History of seizure disorder requiring medication
9. History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
10. History of HIV/AIDS
11. Severe untreated obstructive sleep apnea
12. Greater than three servings alcohol daily or illicit drug use
13. Major neurologic disorders other than dementia (e.g., MS, ALS)
14. Schizophrenia, bipolar disorder, other serious mental illnesses
15. Other significant medical conditions at investigators' discretion
16. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham HD-tDCS combined with CT	sham HD-tDCS combined with CT	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
HD-tDCS combined with CT	HD-tDCS combined with CT	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

Primary Outcome Measures

Name	Time	Method
Treatment completion rates	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Recruitment rate	3 months	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

Trial Locations

Locations (1)

The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States