Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation

• ClinicalTrials.gov Identifier: NCT03143842
• Recruitment Status: Withdrawn
• First Posted: May 8, 2017
• Last Update Posted: January 28, 2022
• Sponsor: The University of Texas at Dallas
• Collaborator: Defense Advanced Research Projects Agency
• Information provided by (Responsible Party): Sven Vanneste, The University of Texas at Dallas

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: April 22, 2020
• Actual Study Completion Date: January 25, 2022

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Sven Vanneste, Ph.D.; The University of Texas at Dallas

More Information

• Responsible Party: Sven Vanneste, Associate professor, The University of Texas at Dallas
• ClinicalTrials.gov Identifier: NCT03143842
• Other Study ID Numbers: 17-47
• First Posted: May 8, 2017
• Last Update Posted: January 28, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Sven Vanneste, The University of Texas at Dallas:

VNS; accelerate learning; memory

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases