Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation

Can we Accelerate Learning in Tinnitus Participants Enrolled in the Vagus Nerve Stimulation (VNS) Study NCT01962558 /13-79?

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.

Study Overview

• Status: Withdrawn
• Conditions: VNS Implanted Tinnitus Patients
• Intervention / Treatment: Device: Vagus Nerve Stimulation

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75080
      • The University of Texas of Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-70 years old
• Native English speaker

Exclusion Criteria:

• Acquainted with the foreign language used in the learning task

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associative Memory assessed by a Verbal Paired-Associate test	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	Baseline session and 1 day, 1 week and 1 month after the baseline session

Collaborators and Investigators

• Sponsor: The University of Texas at Dallas
• Collaborators: Defense Advanced Research Projects Agency
• Investigators: Principal Investigator: Sven Vanneste, Ph.D., The University of Texas at Dallas

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2017
• Primary Completion (ACTUAL): April 22, 2020
• Study Completion (ACTUAL): January 25, 2022

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (ACTUAL): May 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: memory; VNS; accelerate learning
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 17-47

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