Investigating HD-tDCS in Improving Word Finding and Memory Retrieval in Individuals With MCI

Sponsor

The University of Texas at Dallas (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03446508

Collaborator

(none)

Enrollment

Location

Arms

50.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is attempting to improve word finding and memory retrieval problems persons with mild cognitive impairment (MCI) may have.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Device: Active frontal Device: Active parietal Device: Sham	N/A

Detailed Description

This study attempts to improve word finding and memory retrieval problems in persons with mild cognitive impairment (MCI). To remember and find words, the brain has to search for the correct memory and MCI can negatively affect this search. Studies have suggested that low level electrical stimulation of the memory retrieval circuit can improve memory recall. The purpose of this study is to find the exact influence of multi-electrode or High Definition transcranial Direct Current Stimulation (HD-tDCS) by targeting a frontal and a parietal brain area, and their roles in memory retrieval/word finding in MCI. By modulating ongoing activity in 6 sessions of HD-tDCS the study investigates whether HD-tDCS may be used as a way to improve memory retrieval/word finding evaluated by cognitive measures and electroencephalography (EEG) measures before the first session and after the last session of HD-tDCS with a follow-up session 1-month after the stimulation procedure.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Investigating Multi-electrode tDCS in Improving Word Finding and Memory Retrieval in Individuals With Mild Cognitive Impairment

Actual Study Start Date :

Nov 18, 2017

Actual Primary Completion Date :

Jan 25, 2022

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active frontal Active HD-tDCS	Device: Active frontal 1) active HD-tDCS will be administered
Experimental: Active parietal Active HD-tDCS	Device: Active parietal 2) active HD-tDCS will be administered
Sham Comparator: Sham control Sham HD-tDCS	Device: Sham 3) sham HD-tDCS - no current

Arm

Intervention/Treatment

Experimental: Active frontal

Active HD-tDCS

Device: Active frontal

1) active HD-tDCS will be administered

Experimental: Active parietal

Active HD-tDCS

Device: Active parietal

2) active HD-tDCS will be administered

Sham Comparator: Sham control

Sham HD-tDCS

Device: Sham

3) sham HD-tDCS - no current

Outcome Measures

Primary Outcome Measures

Memory retrieval/word finding assessment. [Baseline (before the first HD-tDCS session), immediate post (immediately after the last HD-tDCS session) and 1 month follow up (1 month after the last HD-tDCS session)]
Changes in cognitive performance are compared between the 3 groups to investigate the influence of HD-tDCS on memory retrieval/word finding.

Secondary Outcome Measures

Electroencephalography (EEG). [Baseline (before the first HD-tDCS session), immediate post (immediately after the last HD-tDCS session) and 1 month follow up (1 month after the last HD-tDCS session)]
Brain activity is recorded with electroencephalography (EEG) and is compared between the 3 groups to investigate the influence of HD-tDCS on memory retrieval/word finding.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 40 and 90
Capable of understanding and signing an informed consent
Experiencing severe memory problems

Exclusion Criteria:

Severe organic co-morbidity
Pace maker / defibrillator
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Dallas	Richardson	Texas	United States	78080

Sponsors and Collaborators

The University of Texas at Dallas

Investigators

Principal Investigator: Sven Vanneste, PhD, The University of Texas at Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sven Vanneste, Associate professor, The University of Texas at Dallas

ClinicalTrials.gov Identifier:

NCT03446508

Other Study ID Numbers:

18-21

First Posted:

Feb 26, 2018

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sven Vanneste, Associate professor, The University of Texas at Dallas

High definition transcranial direct stimulation

Mild Cognitive Impairment

Memory

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Feb 8, 2022