Trial Outcomes & Findings for Empower Neuromodulation System - Pilot Study for Anxiety Treatment (NCT NCT04901481)

NCT ID: NCT04901481

Last Updated: 2024-06-20

Results Overview

Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-06-20

Participant Flow

18 participants signed the Informed Consent Form and screened. 12 Subjects were fully enrolled.

Of 18 subjects that signed the Informed Consent, 6 did not meet all of the Inclusion/Exclusion criteria before randomization to a study arm. Therefore, only 12 subjects were fully enrolled and randomized into the trial.

Participant milestones

Measure	Active Treatment Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Baseline characteristics by cohort

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	44 Years n=93 Participants	41 Years n=4 Participants	41 Years n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 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	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	6 Participants n=4 Participants	11 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	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Treatment Adherence	82 Percentage of Treatment Sessions Standard Deviation 19	72 Percentage of Treatment Sessions Standard Deviation 29

PRIMARY outcome

Timeframe: 6 weeks

Acceptability as assessed via a usability assessment (System Usability Scale (SUS)). For the SUS, the score range is 0 to 100, with a higher score indicating the stimulation system's better usability. The survey includes 10 questions in which statements about the system are rated from "Strongly disagree" up to "Strongly agree".

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Usability	73 Units on a scale Standard Deviation 19	77 Units on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: 6 weeks

The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Effective Nerve Stimulation	98 % of treatments that felt skin tingling Standard Deviation 2	100 % of treatments that felt skin tingling Standard Deviation 1

SECONDARY outcome

Timeframe: 6 weeks

The overall satisfaction with treatment (via 100-mm Visual-Analog Scale (VAS)). For the VAS, the score range is 0 to 100, with a higher scoring meaning higher satisfaction.

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Satisfaction With Treatment	52 VAS score Standard Deviation 25	42 VAS score Standard Deviation 22

SECONDARY outcome

Timeframe: 6 weeks

Safety assessment via device-related adverse events

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Number of Participants With Device-related Adverse Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Change in HAM-A score from Baseline to 6 weeks

Anxiety severity evaluation via clinician-administered Hamilton Anxiety Rating Scale (HAM-A) score. For the HAM-A, the score range is 0 to 56, with a higher scoring meaning more severe anxiety.

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks	-6.0 Score Standard Deviation 9.4	-12.2 Score Standard Deviation 4.5

SECONDARY outcome

Timeframe: 6 weeks

Population: Change in BAI score from Baseline to 6 week visit

Anxiety severity evaluation via participant-reported Beck Anxiety Inventory (BAI) score from Baseline to 6 weeks. For the BAI, the score range is 0 to 63, with a higher scoring meaning more severe anxiety.

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks	-2.8 Score Standard Deviation 9.4	-2 Score Standard Deviation 5.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Blinding Index at 6 week visit

Participant blinding to treatment group will be assessed. All participants will be asked if they believe that they have received the real treatment, with possible responses of Yes, No, or Don't Know. Then, for the active and sham treatment groups, the blinding index will be calculated, where the blinding index can range from -1 to 1. A score of 1 means that all participants have guessed correctly about group assignment, a score of -1 means that all participants have guessed incorrectly about group assignment.

Outcome measures

Measure	Active Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 Participants Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Participant Blinding to Treatment Group at 6 Weeks	-0.4 Index Interval -0.58 to -0.22	-0.17 Index Interval -0.4 to 0.07

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Treatment n=6 participants at risk Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 participants at risk Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Infections and infestations Diarrhea	0.00% 0/6 • Adverse events were recorded during the nominal 6 weeks after enrollment.	16.7% 1/6 • Number of events 1 • Adverse events were recorded during the nominal 6 weeks after enrollment.

Other adverse events

Measure	Active Treatment n=6 participants at risk Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.	Sham Treatment n=6 participants at risk Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment. Empower Neuromodulation System: Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • Adverse events were recorded during the nominal 6 weeks after enrollment.	0.00% 0/6 • Adverse events were recorded during the nominal 6 weeks after enrollment.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 2 • Adverse events were recorded during the nominal 6 weeks after enrollment.	0.00% 0/6 • Adverse events were recorded during the nominal 6 weeks after enrollment.
Infections and infestations Nausia	0.00% 0/6 • Adverse events were recorded during the nominal 6 weeks after enrollment.	16.7% 1/6 • Number of events 1 • Adverse events were recorded during the nominal 6 weeks after enrollment.
Infections and infestations Fever	0.00% 0/6 • Adverse events were recorded during the nominal 6 weeks after enrollment.	16.7% 1/6 • Number of events 1 • Adverse events were recorded during the nominal 6 weeks after enrollment.
Product Issues Burning sensation at site of electrodes	0.00% 0/6 • Adverse events were recorded during the nominal 6 weeks after enrollment.	16.7% 1/6 • Number of events 1 • Adverse events were recorded during the nominal 6 weeks after enrollment.

Additional Information

Director of Clinical

TheraNova, LLC

Phone: 4159268616

Email: clinicalstudy@theranova.com

Results disclosure agreements

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