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

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.

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Memory Disorders; Memory Loss
• Intervention / Treatment: Device: HD-tDCS combined with CT; Device: sham HD-tDCS combined with CT

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: HD-tDCS combined with CT; HD-tDCS treatments will be administered during a cognitive training session.
Sham Comparator: 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	Device: sham HD-tDCS combined with CT; sham-HD-tDCS treatments will be administered during a cognitive training session.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Memory Disorders
• Other Study ID Numbers: PRO00035757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No