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

Primary Purpose

Mild Cognitive Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active frontal
Active parietal
Sham
Sponsored by
The University of Texas at Dallas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring High definition transcranial direct stimulation, Mild Cognitive Impairment, Memory

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe organic co-morbidity
  2. Pace maker / defibrillator
  3. Pregnancy

Sites / Locations

  • University of Texas at Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Active frontal

Active parietal

Sham control

Arm Description

Active HD-tDCS

Active HD-tDCS

Sham HD-tDCS

Outcomes

Primary Outcome Measures

Memory retrieval/word finding assessment.
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).
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.

Full Information

First Posted
January 22, 2018
Last Updated
January 25, 2022
Sponsor
The University of Texas at Dallas
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1. Study Identification

Unique Protocol Identification Number
NCT03446508
Brief Title
Investigating HD-tDCS in Improving Word Finding and Memory Retrieval in Individuals With MCI
Official Title
Investigating Multi-electrode tDCS in Improving Word Finding and Memory Retrieval in Individuals With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough participants
Study Start Date
November 18, 2017 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
High definition transcranial direct stimulation, Mild Cognitive Impairment, Memory

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active frontal
Arm Type
Experimental
Arm Description
Active HD-tDCS
Arm Title
Active parietal
Arm Type
Experimental
Arm Description
Active HD-tDCS
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
Sham HD-tDCS
Intervention Type
Device
Intervention Name(s)
Active frontal
Intervention Description
1) active HD-tDCS will be administered
Intervention Type
Device
Intervention Name(s)
Active parietal
Intervention Description
2) active HD-tDCS will be administered
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
3) sham HD-tDCS - no current
Primary Outcome Measure Information:
Title
Memory retrieval/word finding assessment.
Description
Changes in cognitive performance are compared between the 3 groups to investigate the influence of HD-tDCS on memory retrieval/word finding.
Time Frame
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)
Secondary Outcome Measure Information:
Title
Electroencephalography (EEG).
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Vanneste, PhD
Organizational Affiliation
The University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
78080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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