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Trial record 3 of 5 for:    tinnitus vns

Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation

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ClinicalTrials.gov Identifier: NCT03143842
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Defense Advanced Research Projects Agency
Information provided by (Responsible Party):
Sven Vanneste, The University of Texas at Dallas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
VNS Implanted Tinnitus Patients Device: Vagus Nerve Stimulation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Can we Accelerate Learning in Tinnitus Participants Enrolled in the Vagus Nerve Stimulation (VNS) Study NCT01962558 /13-79?
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : April 27, 2018
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Tinnitus

Arm Intervention/treatment
Vagus Nerve Stimulation
VNS paired with word pairs, VNS unpaired with word pairs, no VNS
Device: Vagus Nerve Stimulation
Delivering electrical pulses to the Vagus Nerve




Primary Outcome Measures :
  1. Associative Memory assessed by a Verbal Paired-Associate test [ Time Frame: Baseline session and 1 day, 1 week and 1 month after the baseline session ]
    Changes in performance in the Verbal Paired-Associate memory task is compared between three groups of learned word pairs (1) learned word pairs paired with VNS, (2) learned word pairs unpaired with VNS, (3) learned word pairs paired without VNS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 years old
  • Native English speaker

Exclusion Criteria:

  • Acquainted with the foreign language used in the learning task

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143842


Locations
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United States, Texas
The University of Texas of Dallas
Richardson, Texas, United States, 75080
Sponsors and Collaborators
The University of Texas at Dallas
Defense Advanced Research Projects Agency
Investigators
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Principal Investigator: Sven Vanneste, Ph.D. The University of Texas at Dallas

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Responsible Party: Sven Vanneste, Associate professor, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03143842     History of Changes
Other Study ID Numbers: 17-47
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Sven Vanneste, The University of Texas at Dallas:
VNS
accelerate learning
memory

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms