AnxietyPhase 4NCT04751864
Brain Stimulation & Generalized Anxiety Study
A Phase 4 study testing Cranial Electrotherapy Stimulator (CES) Device in people with Anxiety and Generalized Anxiety Disorder, run by ProofPilot at 1 site in United States.
Trial summary
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device on Generalized Anxiety Disorder using two (2) 20-minute per day treatment sessions over eight weeks. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Generalized Anxiety Disorder, Generalized Anxiety
- What is being tested?
- Cranial Electrotherapy Stimulator (CES) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 21 Jun 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 21
- US resident
- Can receive packages to their home via UPS/Fedex/USPS
- Licensed Physician Diagnosis of Generalized Anxiety Disorder
- Beck Anxiety Inventory Score between 8 and 25
- Read/write English
Show all 23Show fewer
- Have not contemplated suicide in the past year
- Not been institutionalized for mental health issues.
- Not currently experiencing problems with alcohol or drug abuse
- Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
- Can commit to two (2) 20 minute sessions per day for 8 weeks
- Not under medical supervision for serious medical condition
- Not currently being treated for or suspect a mental health issue
- Has not used a brain stimulation treatment in one year
- No suspected or known history of heart disease
- No pacemaker, or any form of medical electronics, including but not limited to a deep - brain stimulator, electronic stent, etc.
- Not taking opioids
- Are a resident of states in which we have licensed medical professionals
- Does not have any co-occurring significant psychiatric disorder that would impair - participant's particationion.
- Does not use any illicit drugs
- Not participating in any other anxiety study
- Not taking medications affecting the nervous system (e.g. psychiatric medications)
- Not taking hypnotics or any sleep aid or marijuana (in any form)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot (Remote Virtual Trial)
New York, New York, 10003
About this study
Official title: Fisher Wallace Brain Stimulation & Generalized Anxiety Study
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device on Generalized Anxiety Disorder using two (2) 20-minute per day treatment sessions over eight weeks.
- Conditions
- Anxiety, Generalized Anxiety Disorder, Generalized Anxiety
- Being tested
- Cranial Electrotherapy Stimulator (CES) Device
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Electrotherapy Stimulator (CES) DeviceDevice
Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Participants receive active device for the full 8 week study Receives: Device: Cranial Electrotherapy Stimulator (CES) Device |
| Sham Arm | Sham comparator | Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device. Receives: Device: Cranial Electrotherapy Stimulator (CES) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Anxiety Inventory (BAI) Score
The Beck is a 21 item self-reported scale measuring anxiety
Measured: baseline versus week 4
Secondary outcomes (4)
Change in Promise Sleep-SD
Change in self reported sleep quality
Measured: baseline versus week 4
Change in Patient Health Questionnaire - 8 (PHQ-8)
self reported depression symptoms
Measured: baseline versus week 4
Change in Beck Anxiety Inventory (BAI) Score
The Beck is a 21 item self-reported scale measuring anxiety
Measured: week 4 versus week 8
Device safety, tolerability and adherence as measured by SAFTEE
The SAFTEE is a self reported measure of side effects associated with mental health treatments
Measured: baseline versus week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start15 Oct 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion21 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fisher Wallace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751864
- Sponsor's protocol ID
- 2503
- Status last verified
- Feb 2021
- First submitted
- 9 Nov 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fisher Wallace Brain Stimulation & Generalized Anxiety Study
- ClinicalTrials.gov ID
- NCT04751864
- Acronym / sponsor ID
- 2503
- Conditions
- Anxiety, Generalized Anxiety Disorder, Generalized Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Fisher Wallace
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 21 Jun 2021 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device on Generalized Anxiety Disorder using two (2) 20-minute per day treatment sessions over eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants randomized into Sham and Active device arms for four weeks. At the week 5 crossover, participants in sham arm receive active device.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Device: Cranial Electrotherapy Stimulator (CES) DeviceParticipants receive active device for the full 8 week study |
| Sham Arm | Sham comparator | Device: Cranial Electrotherapy Stimulator (CES) DeviceParticipants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age greater than 21
- US resident
- Can receive packages to their home via UPS/Fedex/USPS
- Licensed Physician Diagnosis of Generalized Anxiety Disorder
- Beck Anxiety Inventory Score between 8 and 25
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cranial Electrotherapy Stimulator (CES) DeviceFisher Wallace Cranial Electrotherapy Stimulator (CES) Device | Device | Active Arm, Sham Arm |
Primary outcome
Change in Beck Anxiety Inventory (BAI) Score
Time frame: baseline versus week 4
The Beck is a 21 item self-reported scale measuring anxiety
4 secondary outcomes
Change in Promise Sleep-SD
Time frame: baseline versus week 4
Change in Patient Health Questionnaire - 8 (PHQ-8)
Time frame: baseline versus week 4
Change in Beck Anxiety Inventory (BAI) Score
Time frame: week 4 versus week 8
Device safety, tolerability and adherence as measured by SAFTEE
Time frame: baseline versus week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cranial Electrotherapy Stimulator (CES) Device in people with Anxiety and Generalized Anxiety Disorder, run by ProofPilot 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 23 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in Beck Anxiety Inventory (BAI) Score (time frame: baseline versus week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2021.