Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation
Primary Purpose
VNS Implanted Tinnitus Patients
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vagus Nerve Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for VNS Implanted Tinnitus Patients focused on measuring VNS, accelerate learning, memory
Eligibility Criteria
Inclusion Criteria:
- 18-70 years old
- Native English speaker
Exclusion Criteria:
- Acquainted with the foreign language used in the learning task
Sites / Locations
- The University of Texas of Dallas
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vagus Nerve Stimulation
Arm Description
VNS paired with word pairs, VNS unpaired with word pairs, no VNS
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03143842
First Posted
May 4, 2017
Last Updated
January 27, 2022
Sponsor
The University of Texas at Dallas
Collaborators
Defense Advanced Research Projects Agency
1. Study Identification
Unique Protocol Identification Number
NCT03143842
Brief Title
Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation
Official Title
Can we Accelerate Learning in Tinnitus Participants Enrolled in the Vagus Nerve Stimulation (VNS) Study NCT01962558 /13-79?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough participants
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
January 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas
Collaborators
Defense Advanced Research Projects Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
VNS Implanted Tinnitus Patients
Keywords
VNS, accelerate learning, memory
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vagus Nerve Stimulation
Arm Type
Other
Arm Description
VNS paired with word pairs, VNS unpaired with word pairs, no VNS
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation
Intervention Description
Delivering electrical pulses to the Vagus Nerve
Primary Outcome Measure Information:
Title
Associative Memory assessed by a Verbal Paired-Associate test
Description
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
Time Frame
Baseline session and 1 day, 1 week and 1 month after the baseline session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years old
Native English speaker
Exclusion Criteria:
Acquainted with the foreign language used in the learning task
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Vanneste, Ph.D.
Organizational Affiliation
The University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas of Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation
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