Mild Cognitive ImpairmentNCT03446508
Investigating HD-tDCS in Improving Word Finding and Memory Retrieval in Individuals With MCI
A study testing Active frontal and Active parietal in people with Mild Cognitive Impairment, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
This study is attempting to improve word finding and memory retrieval problems persons with mild cognitive impairment (MCI) may have. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Active frontal and Active parietal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2017to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 90
- Capable of understanding and signing an informed consent
- Experiencing severe memory problems
Who cannot join
- Severe organic co-morbidity
- Pace maker / defibrillator
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Dallas
Richardson, Texas, 78080
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Active frontal, Active parietal, Sham
- Keywords
- High definition transcranial direct stimulation, Mild Cognitive Impairment, Memory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active frontalDevice
- active HD-tDCS will be administered
Active parietalDevice
- active HD-tDCS will be administered
ShamDevice
- sham HD-tDCS - no current
| Study group | Role | What they receive |
|---|---|---|
| Active frontal | Experimental | Active HD-tDCS Receives: Device: Active frontal |
| Active parietal | Experimental | Active HD-tDCS Receives: Device: Active parietal |
| Sham control | Sham comparator | Sham HD-tDCS Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start18 Nov 2017
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Why it stopped: Not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Vanneste, The University of Texas at Dallas
- Investigators
- Sven Vanneste, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446508
- Sponsor's protocol ID
- 18-21
- Status last verified
- Jan 2022
- First submitted
- 22 Jan 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Multi-electrode tDCS in Improving Word Finding and Memory Retrieval in Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03446508
- Acronym / sponsor ID
- 18-21
- Conditions
- Mild Cognitive Impairment
- Keywords
- High definition transcranial direct stimulation, Mild Cognitive Impairment, Memory
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active frontal | Experimental | Device: Active frontalActive HD-tDCS |
| Active parietal | Experimental | Device: Active parietalActive HD-tDCS |
| Sham control | Sham comparator | Device: ShamSham HD-tDCS |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40 and 90
- Capable of understanding and signing an informed consent
- Experiencing severe memory problems
Key exclusion criteria (3 listed)
- Severe organic co-morbidity
- Pace maker / defibrillator
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active frontal1) active HD-tDCS will be administered | Device | Active frontal |
| Active parietal2) active HD-tDCS will be administered | Device | Active parietal |
| Sham3) sham HD-tDCS - no current | Device | Sham control |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Vanneste, PhD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active frontal and Active parietal in people with Mild Cognitive Impairment, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.