Generalized Anxiety DisorderNCT04901481
Empower Neuromodulation System - Pilot Study for Anxiety Treatment
A study testing Empower Neuromodulation System in people with Generalized Anxiety Disorder, run by Theranova, L.L.C. at 1 site in United States.
Trial summary
This study evaluates the effects of peripheral nerve stimulation on anxiety levels in participants with Generalized Anxiety Disorder (GAD). This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Empower Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to 17 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥19 years old
- Current diagnosis of GAD per DSM-5 via M.I.N.I. assessment by clinician
- Hamilton Anxiety Rating Scale (HAM-A) ≥18
- Negative urine pregnancy test at screening (females only)
- Able to provide informed consent
- Capable and willing to follow all study-related procedures
Who cannot join
- Has current (past 30 days) psychotic or bipolar disorder, homicidal ideation, psychiatric hospitalization, or moderate/severe substance use disorders per clinician assessment via M.I.N.I.
- Hamilton Depression Rating Scale (HAM-D) ≥18
- PTSD Checklist for DSM-5 (PCL-5) ≥51
- Exhibits suicidal intent as confirmed on the Columbia-Suicide Severity Rating Scale-Revised (C-SSRS-R) with a "Yes" response to question 4 or question 5 or to question 6 in the past 3 months.
- Changes in psychoactive medications in the past 30 days (including but not limited to psychotropic medications, thyroid hormone medication, steroids), with the exception of benzodiazepines
- If regularly taking benzodiazepines, has had changes in benzodiazepine dosing in the past 30 days or average use >2 days per week
Show all 17Show fewer
- Psychotherapy was initiated or discontinued in the past 30 days or psychotherapy modality was changes in the past 30 days
- Has a history of epilepsy or a seizure disorder
- Has been diagnosed with peripheral nerve damage of the arm or hand or has numbness or tingling in the arm or hand at least weekly
- Is currently pregnant or breastfeeding, has been pregnant within the past 6 months or intends to become pregnant during the study period
- Currently has an active implant and/or an electrical or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant
- Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the upper extremities and will directly contact the gel electrodes of the Empower Neuromodulation System at the active or sham anatomic location
- Has an open incision, wound, scar, active infection or otherwise compromised skin that will directly contact the gel electrodes of the Empower Neuromodulation System at either the active or sham anatomic location
- Does not have daily access to an electrical outlet for charging the investigational device and associated smartphone
- Has used of an investigational drug/device therapy within the past four weeks
- Unable to provide informed written consent
- Has any medical condition that would, in the opinion of the investigator, make the participant ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5575
About this study
Official title: Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment
This study evaluates the effects of peripheral nerve stimulation on anxiety levels in participants with Generalized Anxiety Disorder (GAD). This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.
Read the detailed description
Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to treat. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Peripheral nerve stimulation via acupuncture has been shown to directly decrease clinical anxiety scores. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of anxiety. In this study, a randomized, controlled study will be conducted in participants with GAD. Participants will self-administer twice daily treatments with the Empower device. In this pilot study, the primary endpoints will be feasibility and acceptability, with safety and effectiveness evaluated as exploratory endpoints.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Empower Neuromodulation System
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower Neuromodulation SystemDevice
Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | 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. Receives: Device: Empower Neuromodulation System |
| Sham treatment | Sham comparator | 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. Receives: Device: Empower Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant
Measured: 6 weeks
Usability
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".
Measured: 6 weeks
Secondary outcomes (5)
Effective Nerve Stimulation
The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation
Measured: 6 weeks
Satisfaction With Treatment
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.
Measured: 6 weeks
Number of Participants With Device-related Adverse Events
Safety assessment via device-related adverse events
Measured: 6 weeks
Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks
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.
Measured: 6 weeks
Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start17 Sep 2021
- Primary completion28 Jul 2022
- Study completion17 May 2023
Why it stopped: Unable to fully enroll study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 6-week study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Daniel Burnett, MD, Principal investigator, TheraNova, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901481
- Sponsor's protocol ID
- CRD-12-1396-01
- Other IDs
- R43AT011497
- Status last verified
- Apr 2024
- First submitted
- 19 May 2021
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bang, Heejung et al. "Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol." Clinical Research and Regulatory Affairs 27 (2010): 42 - 51.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment
- ClinicalTrials.gov ID
- NCT04901481
- Acronym / sponsor ID
- CRD-12-1396-01
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to fully enroll study.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Nebraska
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of peripheral nerve stimulation on anxiety levels in participants with Generalized Anxiety Disorder (GAD). This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.
Detailed description
Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to treat. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Peripheral nerve stimulation via acupuncture has been shown to directly decrease clinical anxiety scores. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of anxiety. In this study, a randomized, controlled study will be conducted in participants with GAD. Participants will self-administer twice daily treatments with the Empower device. In this pilot study, the primary endpoints will be feasibility and acceptability, with safety and effectiveness evaluated as exploratory endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 6-week study.
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Empower Neuromodulation SystemParticipants 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. |
| Sham treatment | Sham comparator | Device: Empower Neuromodulation SystemParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥19 years old
- Current diagnosis of GAD per DSM-5 via M.I.N.I. assessment by clinician
- Hamilton Anxiety Rating Scale (HAM-A) ≥18
- Negative urine pregnancy test at screening (females only)
- Able to provide informed consent
Key exclusion criteria (17 listed)
- Has current (past 30 days) psychotic or bipolar disorder, homicidal ideation, psychiatric hospitalization, or moderate/severe substance use disorders per clinician assessment via M.I.N.I.
- Hamilton Depression Rating Scale (HAM-D) ≥18
- PTSD Checklist for DSM-5 (PCL-5) ≥51
- Exhibits suicidal intent as confirmed on the Columbia-Suicide Severity Rating Scale-Revised (C-SSRS-R) with a "Yes" response to question 4 or question 5 or to question 6 in the past 3 months.
- Changes in psychoactive medications in the past 30 days (including but not limited to psychotropic medications, thyroid hormone medication, steroids), with the exception of benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empower Neuromodulation SystemPeripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body. | Device | Active treatment, Sham treatment |
Primary outcome
Treatment Adherence
Time frame: 6 weeks
Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant
Usability
Time frame: 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".
5 secondary outcomes
Effective Nerve Stimulation
Time frame: 6 weeks
Satisfaction With Treatment
Time frame: 6 weeks
Number of Participants With Device-related Adverse Events
Time frame: 6 weeks
Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks
Time frame: 6 weeks
Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBang, Heejung et al. "Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol." Clinical Research and Regulatory Affairs 27 (2010): 42 - 51.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Burnett, MD principal investigator
TheraNova, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empower Neuromodulation System in people with Generalized Anxiety Disorder, run by Theranova, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.