Trial Outcomes & Findings for Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder (NCT NCT05226130)

NCT ID: NCT05226130

Last Updated: 2025-07-03

Results Overview

The Treatment Acceptability Questionnaire (TAQ) is a self-rating questionnaire used to assess acceptability of a treatment. The TAQ uses a 7-point rating scale ranging from 1 to 7, with lower scores reflecting lower acceptability and a midpoint of 4 indicating neutral acceptability. A rating above the midpoint of the TAQ (i.e., score between 5 and 7) is the established criterion for "acceptable to highly acceptable".

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 19 participants
• Primary outcome timeframe: Measure administered at study completion (i.e., 1 week after baseline)
• Results posted on: 2025-07-03

Participant Flow

Participant milestones

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Overall Study STARTED	9	10
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Overall Study Lost to Follow-up	0	1
Overall Study Not treatment adherent	0	2

Baseline Characteristics

Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder

Baseline characteristics by cohort

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 8.6 • n=5 Participants	39.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	38.6 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measure administered at study completion (i.e., 1 week after baseline)

Population: TAQ ratings for two subjects (both in the sham group) were not included in the analyses because they were not treatment adherent (i.e., did not self-administer nVNS/sham as instructed). One subject was lost to follow-up.

The Treatment Acceptability Questionnaire (TAQ) is a self-rating questionnaire used to assess acceptability of a treatment. The TAQ uses a 7-point rating scale ranging from 1 to 7, with lower scores reflecting lower acceptability and a midpoint of 4 indicating neutral acceptability. A rating above the midpoint of the TAQ (i.e., score between 5 and 7) is the established criterion for "acceptable to highly acceptable".

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=7 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Treatment Acceptability Questionnaire (TAQ)	5.7 score on a scale Standard Deviation 1.0	6.4 score on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Baseline

Population: More (19 subjects) than the initially proposed number of participants (16 subjects) were enrolled in the study.

Treatment feasibility will be evaluated by meeting the proposed recruitment goal of 16 Veterans within 12 months. This aim was measured as the number of study participants who signed the study consent form, completed at least the baseline study visit, and were included in the study analyses.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Measurement of Feasibility - Recruitment Goal (Data Reflects the Number of Participants Who Were Successfully Enrolled in the Study)	9 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

Population: 1 subject lost to FU

Treatment adherence will be assessed via a daily treatment completion log, and calculated by dividing the total number of times subjects were instructed to self-administer the nVNS/sham stimulation (2x/day for 7 days = 14 times) by the number of times the subjects actually self-administered the stimulation. Treatment feasibility will be evaluated by meeting >75% treatment adherence during the 1-week interval.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Measurement of Feasibility - Treatment Adherence (Number of Times Subjects Self-administered nVNS/Sham Stimulation for 7 Days as Instructed)	94.4 percentage of treatment administrations Standard Deviation 7.8	79.76 percentage of treatment administrations Standard Deviation 26.4

PRIMARY outcome

Timeframe: Baseline to post treatment, up to 21 days post baseline

Treatment feasibility will be evaluated by meeting >75% subject retention at follow-up as measured by the number/percentage of subjects who return for a follow-up visit and complete primary outcome measures and return the device to the study team.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Measurement of Feasibility - Subject Retention (Number/Percentage of Subjects Who Return for a Follow-up Visit)	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

Population: Number of serious adverse events

Treatment feasibility will be evaluated by no occurrence of serious adverse side effects (as documented in checklist/daily log, interview at study completion, or otherwise reported by the participant).

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Measurement of Feasibility - Serious Adverse Side Effects	0 Number of serious adverse events	0 Number of serious adverse events

SECONDARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

The Substance Use Recovery Evaluator (SURE) assesses the following domains of AUD-related functional outcomes: self-care (mental and physical health), relationships, material resources (stability of housing and occupational resources), and outlook of life. The SURE has been developed for use in substance use disorder populations. The SURE is comprised of 21 items, rated on a 3-point scale, but scored using a 3-point scale. Scores range from 21-63. A higher score indicates better functional outcomes.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Substance Use Recovery Evaluator (SURE) Baseline	44.7 score on a scale Standard Deviation 7.8	44.0 score on a scale Standard Deviation 5.7
Substance Use Recovery Evaluator (SURE) Follow-up	50.6 score on a scale Standard Deviation 10.5	44.9 score on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

The WHO Quality of Life assessment (WHOQOL-BREF) assesses quality of life across four domains (physical health, psychological, social relationships, and environment) with a total of 26 questions. The rating scale ranges from 1 to 5 and minimum and maximum values varies between domains (physical health: 7-35, psychological: 6-30, social relationships: 3-15, environment: 8-40). Higher scores denote higher quality of life. Reported here are results from the psychological domain.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
WHO Quality of Life Assessment (WHOQOL-BREF) - Psychological Domain Baseline	14.2 score on a scale Standard Deviation 4.1	17.8 score on a scale Standard Deviation 4.0
WHO Quality of Life Assessment (WHOQOL-BREF) - Psychological Domain Follow-up	16.8 score on a scale Standard Deviation 4.4	17.4 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

The Beck Anxiety Inventory (BAI) is a self-report instrument to measure the severity of anxiety and emotional distress. The BAI is a 21-item questionnaire with a 4-point rating scale (0-3), with a higher score reflecting greater anxiety. Total scores range from 0 to 63 with higher scores indicating higher anxiety.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Beck Anxiety Inventory (BAI) Baseline	16.8 score on a scale Standard Deviation 9.2	17.0 score on a scale Standard Deviation 11.6
Beck Anxiety Inventory (BAI) Follow-up	12.5 score on a scale Standard Deviation 10.0	17.6 score on a scale Standard Deviation 17.8

SECONDARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

The PROMIS Pain Interference measures self-reported consequences of pain on relevant aspects of one's life, i.e., the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. This questionnaire has 8 items with ratings ranging from "not at all" to "very much". Total score minimum is 8 and the maximum is 40. Higher scores reflect higher interference of pain with level of functioning.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
PROMIS Pain Interference Baseline	22.4 score on a scale Standard Deviation 8.3	23.6 score on a scale Standard Deviation 9.7
PROMIS Pain Interference Follow-up	20.9 score on a scale Standard Deviation 8.2	21.8 score on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline to week 1 of 2x daily intervention

The Alcohol Urge Questionnaire (AUQ) is 8-item scale that measures cognitive preoccupation with alcohol on a 7-point rating scale ranging from "strongly disagree" to "strongly agree". Two items are reverse scored. Minimum score is 8 and maximum is 56. Higher scores reflect greater craving.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Alcohol Urge Questionnaire (AUQ) Baseline	25.6 score on a scale Standard Deviation 11.3	25.7 score on a scale Standard Deviation 10.8
Alcohol Urge Questionnaire (AUQ) Follow-up	18.4 score on a scale Standard Deviation 9.8	21.2 score on a scale Standard Deviation 8.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 1 of 2x daily intervention

Population: Two subjects did not participate in neuroimaging scans due to claustrophobia.

Participants receive brief thermal stimuli (experienced temperature ranging from warm to hot) applied to the leg via a contact thermode during a functional magnetic resonance imaging scan. Neural activation will be measured using the general linear model (GLM) to estimate beta coefficients for the BOLD (blood-oxygen-level-dependent) signal in response to thermal stimulation. Activation in the brain region insula will be summarized by calculating the area under the beta response curve (arbitrary units) over the stimulus duration (i.e., time), reflecting the total magnitude of neural activation. BOLD signal and beta coefficients used to model neural response are in arbitrary units. The area under the curve is the cumulative scaled beta (i.e., cumulative percent signal change) that is most reflective of the activation attributable to the stimulus. Higher numbers indicate more neural activation in the insula in response to painful heat stimuli.

Outcome measures

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 Participants Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=8 Participants Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Neural Response to Heat Pain Stimuli (Measured as Sum of BOLD Beta Coefficients Over Time in Arbitrary Units) Baseline	-0.48 Arbitrary units Standard Deviation 0.25	-0.37 Arbitrary units Standard Deviation 0.27
Neural Response to Heat Pain Stimuli (Measured as Sum of BOLD Beta Coefficients Over Time in Arbitrary Units) Follow-up	-0.38 Arbitrary units Standard Deviation 0.24	1.00 Arbitrary units Standard Deviation 1.21

Adverse Events

Active Cervical Transcutaneous Vagus Nerve Stimulation

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham Cervical Transcutaneous Vagus Nerve Stimulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Cervical Transcutaneous Vagus Nerve Stimulation n=9 participants at risk Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (active comparator): Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.	Sham Cervical Transcutaneous Vagus Nerve Stimulation n=10 participants at risk Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week. Cervical transcutaneous vagus nerve stimulation (sham comparator): Sham nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that does not stimulate the vagus nerve.
Product Issues Lip pulling	22.2% 2/9 • Number of events 2 • 7 days \[Not Specified\]	0.00% 0/10 • 7 days \[Not Specified\]
Product Issues Tingling sensation	22.2% 2/9 • Number of events 2 • 7 days \[Not Specified\]	0.00% 0/10 • 7 days \[Not Specified\]
Product Issues Muscle twitching	22.2% 2/9 • Number of events 2 • 7 days \[Not Specified\]	0.00% 0/10 • 7 days \[Not Specified\]
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • 7 days \[Not Specified\]	10.0% 1/10 • Number of events 1 • 7 days \[Not Specified\]
Nervous system disorders Mild headache	11.1% 1/9 • Number of events 1 • 7 days \[Not Specified\]	0.00% 0/10 • 7 days \[Not Specified\]
Product Issues Neck soreness	0.00% 0/9 • 7 days \[Not Specified\]	10.0% 1/10 • Number of events 1 • 7 days \[Not Specified\]

Additional Information

Ruth Klaming, PhD

VA San Diego Healthcare System, San Diego, CA

Phone: 858-552-8585

Email: rklaming@health.ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place