Clinical trial NCT03143842: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: VNS Implanted Tinnitus Patients
Keywords: VNS
accelerate learning
memory
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: Defense Advanced Research Projects Agency
First posted: 2017-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Native English speaker

Exclusion Criteria:

* Acquainted with the foreign language used in the learning task

Primary outcomes:
measure: Associative Memory assessed by a Verbal Paired-Associate test
timeFrame: Baseline session and 1 day, 1 week and 1 month after the baseline session
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The University of Texas of Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: