NCT03446508

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

4.2 years

First QC Date

January 22, 2018

Last Update Submit

January 25, 2022

Conditions

Mild Cognitive Impairment

Keywords

High definition transcranial direct stimulationMild Cognitive ImpairmentMemory

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • 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)

Study Arms (3)

Active frontal

EXPERIMENTAL

Active HD-tDCS

Device: Active frontal

Active parietal

EXPERIMENTAL

Active HD-tDCS

Device: Active parietal

Sham control

SHAM COMPARATOR

Sham HD-tDCS

Device: Sham

Interventions

Active frontalDEVICE

1\) active HD-tDCS will be administered

Active frontal
Active parietalDEVICE

2\) active HD-tDCS will be administered

Active parietal
ShamDEVICE

3\) sham HD-tDCS - no current

Sham control

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe organic co-morbidity
  • Pace maker / defibrillator
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Dallas

Richardson, Texas, 78080, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Sven Vanneste, PhD

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

February 26, 2018

Study Start

November 18, 2017

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations

US(1)