Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation

NCT03143842 | Withdrawn FDA Device

• 1 other identifier: 17-47
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

VNS Implanted Tinnitus Patients

Keywords

VNS; accelerate learning; memory

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vagus Nerve Stimulation

OTHER

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

Device: Vagus Nerve Stimulation

Interventions

Vagus Nerve Stimulation DEVICE

Delivering electrical pulses to the Vagus Nerve

Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Native English speaker

You may not qualify if:

• Acquainted with the foreign language used in the learning task

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• Defense Advanced Research Projects Agency: collaborator

Study Sites (1)

The University of Texas of Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Sven Vanneste, Ph.D.

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: April 27, 2017
• Primary Completion: April 22, 2020
• Study Completion: January 25, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

US (1)