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

Mild Cognitive Impairment Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246164
• Other study ID #: PRO00035757
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: February 23, 2023

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Memory Disorders
• Memory Loss
• Mild Cognitive Impairment

Intervention

Device:
• HD-tDCS combined with CT
HD-tDCS treatments will be administered during a cognitive training session.
• sham HD-tDCS combined with CT
sham-HD-tDCS treatments will be administered during a cognitive training session.

Locations

Country	Name	City	State
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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