PTSDNCT06050590
NeuroGlove PTSD Study
A study testing NeuroGlove in people with PTSD and Post Traumatic Stress Disorder, run by NeuroGlove LLC at 1 site in United States.
Trial summary
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- NeuroGlove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
- Men and women ≥18 and <85 years of age.
- Carry an active diagnosis of PTSD.
- Suffer from PTSD symptoms that impact subject's daily activities and quality of life.
Who cannot join
- Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
- Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.
Read the detailed description
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.
There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove.
The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- NeuroGlove
- Keywords
- PTSD, Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroGloveDevice
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.
| Study group | Role | What they receive |
|---|---|---|
| NeuroGlove Treatment Arm | Experimental | Study participants undergoing treatment using the NeuroGlove. Receives: Device: NeuroGlove |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Reduction
Change in PTSD symptoms and subject's sense of well-being
Measured: 4 weeks
Portion of participants with adverse events
Rate and severity of adverse events related to the use of the NeuroGlove.
Measured: 4 weeks
Secondary outcomes (1)
PTSD Symptom Severity
Change in severity of symptoms related to PTSD using NSESSS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start14 Aug 2023
- Primary completion27 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- NeuroGlove
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroGlove LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Nussbaum, MD, Principal investigator, NeuroGlove LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050590
- Sponsor's protocol ID
- REG-1003
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data will only be used by the sponsor organization and investigators.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT06050590
- Acronym / sponsor ID
- REG-1003
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Keywords
- PTSD, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- NeuroGlove LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 27 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 22 Sep 2023 (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.
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.
Detailed description
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.
There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove.
The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NeuroGlove
| Arm | Type | Receives |
|---|---|---|
| NeuroGlove Treatment Arm | Experimental | Device: NeuroGloveStudy participants undergoing treatment using the NeuroGlove. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
- Men and women ≥18 and <85 years of age.
- Carry an active diagnosis of PTSD.
- Suffer from PTSD symptoms that impact subject's daily activities and quality of life.
Key exclusion criteria (3 listed)
- Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
- Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
- Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
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 |
|---|---|---|
| NeuroGloveStudy participant with PTSD will undergo daily at home treatment using the NeuroGlove. | Device | NeuroGlove Treatment Arm |
Primary outcome
PTSD Symptom Reduction
Time frame: 4 weeks
Change in PTSD symptoms and subject's sense of well-being
Portion of participants with adverse events
Time frame: 4 weeks
Rate and severity of adverse events related to the use of the NeuroGlove.
1 secondary outcome
PTSD Symptom Severity
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No. The data will only be used by the sponsor organization and investigators.
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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.
Eric Nussbaum, MD principal investigator
NeuroGlove 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 NeuroGlove in people with PTSD and Post Traumatic Stress Disorder, run by NeuroGlove LLC 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Aug 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. 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?
Results are not available in the source record.
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?
PTSD Symptom Reduction (time frame: 4 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?
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 27 Aug 2024.