Back to resultsA Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
Primary Purpose
Mild Cognitive Impairment, Memory Disorders, Memory Loss
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HD-tDCS combined with CT
sham HD-tDCS combined with CT
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
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
Sites / Locations
- The Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
HD-tDCS combined with CT
sham HD-tDCS combined with CT
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04246164
First Posted
January 27, 2020
Last Updated
November 17, 2021
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT04246164
Brief Title
A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Memory Disorders, Memory Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double-blinded
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HD-tDCS combined with CT
Arm Type
Active Comparator
Arm 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
Arm Title
sham HD-tDCS combined with CT
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
HD-tDCS combined with CT
Intervention Description
HD-tDCS treatments will be administered during a cognitive training session.
Intervention Type
Device
Intervention Name(s)
sham HD-tDCS combined with CT
Intervention Description
sham-HD-tDCS treatments will be administered during a cognitive training session.
Primary Outcome Measure Information:
Title
Treatment completion rates
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
We'll reach out to this number within 24 hrs