Trial Outcomes & Findings for Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation (NCT NCT03359902)
NCT ID: NCT03359902
Last Updated: 2023-10-24
Results Overview
The Rey Auditory Verbal Learning Test (RAVLT) is a verbal learning and memory task with a 15-item word list learned over 5 trials. The total delayed recall score is the number of total correct words recalled (ranging from 0 to 15) after a 30 minute delay.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-list
Results posted on
2023-10-24
Participant Flow
Participant milestones
| Measure |
Sham First, Then tVNS
This group will receive sham stimulation, initially. Participants will be randomized between the two arms of the crossover sessions (tVNS first, then sham vs. sham first, then tVNS). Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Transcutaneous vagal nerve stimulation: Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
Sham stimulation: Sham stimulation will be performed using electrodes placed on earlobe
|
tVNS First, Then Sham
This group will receive transcutaneous vagal nerve stimulation, initially. Participants will be randomized between the two arms of the crossover sessions (tVNS first, then sham vs. sham first, then tVNS). Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Transcutaneous vagal nerve stimulation: Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
Sham stimulation: Sham stimulation will be performed using electrodes placed on earlobe
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
18
|
|
Overall Study
COMPLETED
|
41
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation
Baseline characteristics by cohort
| Measure |
Initial Sham
n=41 Participants
This group will receive sham stimulation, initially. Participants will be randomized between the two arms of the crossover sessions (initial tVNS vs. initial Sham). Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Transcutaneous vagal nerve stimulation: Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
Sham stimulation: Sham stimulation will be performed using electrodes placed on earlobe
|
Initial tVNS
n=18 Participants
This group will receive transcutaneous vagal nerve stimulation, initially. Participants will be randomized between the two arms of the crossover sessions (initial tVNS vs. initial Sham). Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Transcutaneous vagal nerve stimulation: Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
Sham stimulation: Sham stimulation will be performed using electrodes placed on earlobe
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.56 years
STANDARD_DEVIATION 7.36 • n=93 Participants
|
75.94 years
STANDARD_DEVIATION 6.96 • n=4 Participants
|
75.81 years
STANDARD_DEVIATION 7.18 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Years of Education
|
15.93 years
STANDARD_DEVIATION 2.78 • n=93 Participants
|
16.44 years
STANDARD_DEVIATION 2.78 • n=4 Participants
|
16.08 years
STANDARD_DEVIATION 2.77 • n=27 Participants
|
|
Wechsler Test of Adult Reading (standard score)
|
112.35 units on a scale
STANDARD_DEVIATION 12.11 • n=93 Participants
|
110.89 units on a scale
STANDARD_DEVIATION 12.07 • n=4 Participants
|
111.9 units on a scale
STANDARD_DEVIATION 12.01 • n=27 Participants
|
|
Beck Depression Inventory-2
|
8.32 units on a scale
STANDARD_DEVIATION 6.99 • n=93 Participants
|
8.06 units on a scale
STANDARD_DEVIATION 6.32 • n=4 Participants
|
8.24 units on a scale
STANDARD_DEVIATION 6.73 • n=27 Participants
|
|
Clinical Dementia Rating Scale (sum of boxes)
|
0.66 units on a scale
STANDARD_DEVIATION 1.18 • n=93 Participants
|
0.44 units on a scale
STANDARD_DEVIATION 0.16 • n=4 Participants
|
0.59 units on a scale
STANDARD_DEVIATION 0.99 • n=27 Participants
|
|
Functional Activities Questionnaire
|
3.27 units on a scale
STANDARD_DEVIATION 3 • n=93 Participants
|
2.89 units on a scale
STANDARD_DEVIATION 2.74 • n=4 Participants
|
3.15 units on a scale
STANDARD_DEVIATION 2.91 • n=27 Participants
|
|
Hopkins Verbal Learning Test (total immediate recall)
|
17.46 units on a scale
STANDARD_DEVIATION 4.61 • n=93 Participants
|
15.47 units on a scale
STANDARD_DEVIATION 3.94 • n=4 Participants
|
16.88 units on a scale
STANDARD_DEVIATION 4.48 • n=27 Participants
|
|
Hopkins Verbal Learning Test (total delayed recall)
|
1.71 units on a scale
STANDARD_DEVIATION 2.44 • n=93 Participants
|
1.94 units on a scale
STANDARD_DEVIATION 2.97 • n=4 Participants
|
1.78 units on a scale
STANDARD_DEVIATION 2.58 • n=27 Participants
|
|
Hopkins Verbal Learning Test (total retention)
|
22.62 units on a scale
STANDARD_DEVIATION 30.03 • n=93 Participants
|
26.67 units on a scale
STANDARD_DEVIATION 40.44 • n=4 Participants
|
23.81 units on a scale
STANDARD_DEVIATION 33.10 • n=27 Participants
|
|
Hopkins Verbal Learning Test (recognition)
|
7.37 units on a scale
STANDARD_DEVIATION 2.67 • n=93 Participants
|
7.35 units on a scale
STANDARD_DEVIATION 3.41 • n=4 Participants
|
7.36 units on a scale
STANDARD_DEVIATION 2.88 • n=27 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after administration of 5 list learning trials; 2 minutes to complete delayed recall of word-listPopulation: As a crossover design, each participant operated as their own control. Therefore results of data analysis are presented per intervention (i.e., tVNS vs. Sham) rather than per arm (i.e., first tVNS, then Sham, etc.).
The Rey Auditory Verbal Learning Test (RAVLT) is a verbal learning and memory task with a 15-item word list learned over 5 trials. The total delayed recall score is the number of total correct words recalled (ranging from 0 to 15) after a 30 minute delay.
Outcome measures
| Measure |
Sham
n=58 Participants
This is the sham arm for all participants.
Sham stimulation: Sham stimulation will be performed using electrodes placed on earlobe
|
tVNS
n=58 Participants
This is the active stimulation arm of all participants.
Behavioral portions of the testing will then be carried out twice, with at least 72 hours between sessions (to avoid carryover effects).
Transcutaneous vagal nerve stimulation: Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
|
|---|---|---|
|
Rey Auditory Verbal Learning Test (Total Delayed Recall)
|
6.43 score on a scale
Interval 0.0 to 15.0
|
7.83 score on a scale
Interval 0.0 to 15.0
|
Adverse Events
Initial Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Initial tVNS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place