PainNCT06276881
Visual Stimulation for Pain Relief
A study testing Visual Stimulation in people with Pain, run by Dandelion Science Sàrl at 1 site in United States.
Trial summary
The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Visual Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 1 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants of both sexes
- Participants of diverse ethnic and racial backgrounds
- Participants who speak, read, and understand English and are willing and able to provide written informed
- 18 to 50 years old
Who cannot join
- Participants with neurologic, endocrine, renal, gastrointestinal, and chronic pain disease
- Participants who use unprescribed drugs or medications
- Chronically medicated participants
- Participants with photosensitivity and epileptic seizures
- Participants who have undergone major surgery within two months of the experiment date
- Participants with cardiac disorders
Show all 11Show fewer
- Participants who are pregnant
- Prisoners
- Participants who are unable to provide consent
- Participants diagnosed with a psychiatric disorder that is likely to interfere with the conduct of the study
- Participants with implanted electronic devices of any kind, including pace-makers, electronic infusion pumps, stimulators, defibrillators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relief Through Artificial Intelligence (AI) -Guided Dynamic Neuromodulation
The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.
- Conditions
- Pain
- Being tested
- Visual Stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual StimulationBehavioural
AI-guided visual stimuli presented on an electronic screen
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Not described Receives: Behavioral: Visual Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Score
Standard computerized scale of perceived pain level. The scale ranges from 0 to 100, a score of "0" indicating "No Pain" and a score of "100" indicating "Most Pain". Higher score indicates a worse outcome as perceived pain is increasing, lower score indicates a better outcome as perceived pain is decreasing.
Measured: Up to 2 hours
Event-related Potential (ERP)
Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start3 Jun 2022
- Primary completion28 Dec 2022
- Study completion1 May 2023
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.
- Other trials for PainStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dandelion Science Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Chief Executive Officer (CEO), Principal investigator, Dandelion Science Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276881
- Sponsor's protocol ID
- DSC1001
- Other IDs
- 1R43DA054845-01
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2024
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief Through Artificial Intelligence (AI) -Guided Dynamic Neuromodulation
- ClinicalTrials.gov ID
- NCT06276881
- Acronym / sponsor ID
- DSC1001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dandelion Science SàrlIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Behavioral: Visual Stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants of both sexes
- Participants of diverse ethnic and racial backgrounds
- Participants who speak, read, and understand English and are willing and able to provide written informed
- 18 to 50 years old
Key exclusion criteria (11 listed)
- Participants with neurologic, endocrine, renal, gastrointestinal, and chronic pain disease
- Participants who use unprescribed drugs or medications
- Chronically medicated participants
- Participants with photosensitivity and epileptic seizures
- Participants who have undergone major surgery within two months of the experiment date
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 |
|---|---|---|
| Visual StimulationAI-guided visual stimuli presented on an electronic screen | Behavioural | Healthy Controls |
Primary outcome
Visual Analog Scale (VAS) Score
Time frame: Up to 2 hours
Standard computerized scale of perceived pain level. The scale ranges from 0 to 100, a score of "0" indicating "No Pain" and a score of "100" indicating "Most Pain". Higher score indicates a worse outcome as perceived pain is increasing, lower score indicates a better outcome as perceived pain is decreasing.
Event-related Potential (ERP)
Time frame: Up to 2 hours
Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Chief Executive Officer (CEO) principal investigator
Dandelion Science Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Stimulation in people with Pain, run by Dandelion Science Sàrl 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 11 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: finished, as of the sponsor's last update on 7 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?
Yes. Results are posted in the registry (first posted 3 Apr 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?
Visual Analog Scale (VAS) Score (time frame: Up to 2 hours). 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 7 Aug 2024.