- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03446508
Investigating HD-tDCS in Improving Word Finding and Memory Retrieval in Individuals With MCI
January 25, 2022 updated by: Sven Vanneste, The University of Texas at Dallas
Investigating Multi-electrode tDCS in Improving Word Finding and Memory Retrieval in Individuals With Mild Cognitive Impairment
This study is attempting to improve word finding and memory retrieval problems persons with mild cognitive impairment (MCI) may have.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Richardson, Texas, United States, 78080
- University of Texas at Dallas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active frontal
Active HD-tDCS
|
1) active HD-tDCS will be administered
|
Experimental: Active parietal
Active HD-tDCS
|
2) active HD-tDCS will be administered
|
Sham Comparator: Sham control
Sham HD-tDCS
|
3) sham HD-tDCS - no current
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory retrieval/word finding assessment.
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroencephalography (EEG).
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)
|
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.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sven Vanneste, PhD, The University of Texas at Dallas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2017
Primary Completion (Actual)
January 25, 2022
Study Completion (Actual)
January 25, 2022
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
February 22, 2018
First Posted (Actual)
February 26, 2018
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
January 25, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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