Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation

NCT ID: NCT03143842

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2022-01-25

Brief Summary

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The purpose of this study is to investigate whether it is possible to accelerate learning and improve memory performance in VNS implanted tinnitus participants by pairing VNS with a verbal paired-associate learning task.

Detailed Description

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Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Vagus Nerve Stimulation (VNS) has been delivered to patient populations (e.g. depression, epilepsy, …) for more than 25 years and there has been some indications that this technique has effects on cognition, more specifically memory. Studies have investigated VNS as a way to improve memory performance and it has been shown in some studies to enhance memory in rats and humans. It has also demonstrated to produce changes in the electrophysiological and metabolic profile of forebrain and brainstem structures involved in learning and memory.

To investigate whether VNS can accelerate learning and improve associative memory when learning word pairs, we will investigate the performance of VNS implanted participants on a Verbal Paired-Associate memory task and compare their performance on the words that were learned while paired with VNS in contrast to their performance on the words that were learned while unpaired with VNS and in contrast to their performance on the words that were learned without VNS (i.e. 3 types/groups of words: paired with VNS, unpaired with VNS and without VNS) during the first visit and 1 day,1 week and 1 month after their first visit.

Conditions

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VNS Implanted Tinnitus Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Within-subject design:

To investigate whether VNS can accelerate learning and improve associative memory when learning word pairs, we will investigate the performance of VNS implanted participants on a Verbal Paired-Associate memory task and compare their performance on the words that were learned while paired with VNS in contrast to their performance on the words that were learned while unpaired with VNS and in contrast to their performance on the words that were learned without VNS (i.e. 3 types/groups of words: paired with VNS, unpaired with VNS and without VNS) during the first visit and 1 day,1 week and 1 month after their first visit.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vagus Nerve Stimulation

VNS paired with word pairs, VNS unpaired with word pairs, no VNS

Group Type OTHER

Vagus Nerve Stimulation

Intervention Type DEVICE

Delivering electrical pulses to the Vagus Nerve

Interventions

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Vagus Nerve Stimulation

Delivering electrical pulses to the Vagus Nerve

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-70 years old
* Native English speaker

Exclusion Criteria

* Acquainted with the foreign language used in the learning task
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Defense Advanced Research Projects Agency

FED

Sponsor Role collaborator

The University of Texas at Dallas

OTHER

Sponsor Role lead

Responsible Party

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Sven Vanneste

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven Vanneste, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Dallas

Locations

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The University of Texas of Dallas

Richardson, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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17-47

Identifier Type: -

Identifier Source: org_study_id

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