PainNCT06510244
Pain Perception Measurement by EEG and NRS
An observational study of Pain and Electroencephalography, run by Cleveland Dental Institute at 1 site in United States.
Trial summary
Observational study at CDI Cleveland Dental Institute. Investigators will assess the pain perception in one group of patients using two non-invasive methods. First, a numerical rate scale (NRS) and second, a brain wave EEG. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pain, Electroencephalography, Toothache
- What is being tested?
- EEG EMOTIV
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Apr 2025
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Adult
Study population: In the outpatient clinic of CDI Cleveland Dental Institute, patients with mature and vital tooth #8 are between 20 and 60 years old.
Who may be able to join
- Males and females
- Age: 20-60 years.
- Tooth #8 vital and mature. No history of dentoalveolar trauma.
- Adequate coronal tooth structure.
Who cannot join
- Chronic periodontitis.
- Vertical root fracture.
- Immature teeth.
- Necrotic teeth.
- Systemic diseases that affect the healing process.
- Non restorable teeth.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cleveland Dental Institute
Cleveland, Ohio, 44128
Ulises Carballosa, Resident, 786-690-1609, u.carballosa@cdiohio.org
Dania Mustafa, Resident, 5038510616, d.mustafa@cdiohio.org
About this study
Official title: Measuring Pain Perception to the Same Stimulus in Different Patients Using Electroencephalography and Numerical Rate Scale
Observational study at CDI Cleveland Dental Institute. Investigators will assess the pain perception in one group of patients using two non-invasive methods. First, a numerical rate scale (NRS) and second, a brain wave EEG.
Read the detailed description
To generate the nociceptive stimulus, The investigators will apply cold (Endo-Ice) to a healthy upper incisor tooth #8. Inclusion criteria: Patients between 20 and 60 years old, with healthy teeth, no history of dental alveolar trauma, and no pulp chamber calcification. After the nociceptive stimulus, patients will write their pain perception on paper from 0 to 10, and at the same time, we will record the brain activity with a non-invasive EEG Emotiv. Then, we will correlate both methods.
- Conditions
- Pain, Electroencephalography, Toothache
- Being tested
- EEG EMOTIV
- Keywords
- pain perception, Numeric Pain Rating Scale, electroencephalography
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG EMOTIVDevice
Also called Noninvasive Electroencephalography, Endo-Ice
The teeth will be dried with 2x2 gauze; then, Endo Ice will be applied. The patient response will be written on a sheet numbering to choose from 0 to 10, and at the same time, the brain waves will be recorded through EEG.
| Study group | Role | What they receive |
|---|---|---|
| One group of patients between 20-60 years old | Patients between 20-60 years old with a tooth health and no history of dental alveolar trauma or pulp chamber calcification. Receives: Device: EEG EMOTIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception Measurement by EEG.
to observe the brain waves changes during pain perception
Measured: January 2024-December 2024
Pain Perception Measurement by EEG and NRS.
To establish a possible correlation between the NRS and EEG measurements.
Measured: January 2024-December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Dental Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510244
- Sponsor's protocol ID
- CDIENDO0002
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alcock MM. Defining pain: past, present, and future. Pain. 2017 Apr;158(4):761-762. doi: 10.1097/j.pain.0000000000000828. No abstract available.
PubMed 28301403Matsuda S, Itoi H, Ryoke T, Yoshimura H. How should clinicians assess acute dental pain?: A review. Medicine (Baltimore). 2022 Nov 11;101(45):e31727. doi: 10.1097/MD.0000000000031727.
PubMed 36397373Mouraux A, Iannetti GD. The search for pain biomarkers in the human brain. Brain. 2018 Dec 1;141(12):3290-3307. doi: 10.1093/brain/awy281.
PubMed 30462175Mussigmann T, Bardel B, Lefaucheur JP. Resting-state electroencephalography (EEG) biomarkers of chronic neuropathic pain. A systematic review. Neuroimage. 2022 Sep;258:119351. doi: 10.1016/j.neuroimage.2022.119351. Epub 2022 Jun 2.
PubMed 35659993Ploner M, Sorg C, Gross J. Brain Rhythms of Pain. Trends Cogn Sci. 2017 Feb;21(2):100-110. doi: 10.1016/j.tics.2016.12.001. Epub 2016 Dec 23.
PubMed 28025007May ES, Nickel MM, Ta Dinh S, Tiemann L, Heitmann H, Voth I, Tolle TR, Gross J, Ploner M. Prefrontal gamma oscillations reflect ongoing pain intensity in chronic back pain patients. Hum Brain Mapp. 2019 Jan;40(1):293-305. doi: 10.1002/hbm.24373. Epub 2018 Sep 10.
PubMed 30260531Holsheimer J, Feenstra BW. Volume conduction and EEG measurements within the brain: a quantitative approach to the influence of electrical spread on the linear relationship of activity measured at different locations. Electroencephalogr Clin Neurophysiol. 1977 Jul;43(1):52-8. doi: 10.1016/0013-4694(77)90194-8.
PubMed 68872
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Pain Perception to the Same Stimulus in Different Patients Using Electroencephalography and Numerical Rate Scale
- ClinicalTrials.gov ID
- NCT06510244
- Acronym / sponsor ID
- CDIENDO0002
- Conditions
- Pain, Electroencephalography, Toothache
- Keywords
- pain perception, Numeric Pain Rating Scale, electroencephalography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cleveland Dental InstituteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Jul 2024 (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.
Observational study at CDI Cleveland Dental Institute. Investigators will assess the pain perception in one group of patients using two non-invasive methods. First, a numerical rate scale (NRS) and second, a brain wave EEG.
Detailed description
To generate the nociceptive stimulus, The investigators will apply cold (Endo-Ice) to a healthy upper incisor tooth #8. Inclusion criteria: Patients between 20 and 60 years old, with healthy teeth, no history of dental alveolar trauma, and no pulp chamber calcification. After the nociceptive stimulus, patients will write their pain perception on paper from 0 to 10, and at the same time, we will record the brain activity with a non-invasive EEG Emotiv. Then, we will correlate both methods.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group of patients between 20-60 years old | – | Device: EEG EMOTIVPatients between 20-60 years old with a tooth health and no history of dental alveolar trauma or pulp chamber calcification. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- In the outpatient clinic of CDI Cleveland Dental Institute, patients with mature and vital tooth #8 are between 20 and 60 years old.
Key inclusion criteria (4 listed)
- Males and females
- Age: 20-60 years.
- Tooth #8 vital and mature. No history of dentoalveolar trauma.
- Adequate coronal tooth structure.
Key exclusion criteria (6 listed)
- Chronic periodontitis.
- Vertical root fracture.
- Immature teeth.
- Necrotic teeth.
- Systemic diseases that affect the healing process.
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 |
|---|---|---|
| EEG EMOTIVAlso: Noninvasive Electroencephalography, Endo-IceThe teeth will be dried with 2x2 gauze; then, Endo Ice will be applied. The patient response will be written on a sheet numbering to choose from 0 to 10, and at the same time, the brain waves will be recorded through EEG. | Device | One group of patients between 20-60 years old |
Primary outcome
Pain Perception Measurement by EEG.
Time frame: January 2024-December 2024
to observe the brain waves changes during pain perception
Pain Perception Measurement by EEG and NRS.
Time frame: January 2024-December 2024
To establish a possible correlation between the NRS and EEG measurements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 28301403Alcock MM. Defining pain: past, present, and future. Pain. 2017 Apr;158(4):761-762. doi: 10.1097/j.pain.0000000000000828. No abstract available.
- Background: PubMed 36397373Matsuda S, Itoi H, Ryoke T, Yoshimura H. How should clinicians assess acute dental pain?: A review. Medicine (Baltimore). 2022 Nov 11;101(45):e31727. doi: 10.1097/MD.0000000000031727.
- Background: PubMed 30462175Mouraux A, Iannetti GD. The search for pain biomarkers in the human brain. Brain. 2018 Dec 1;141(12):3290-3307. doi: 10.1093/brain/awy281.
- Background: PubMed 35659993Mussigmann T, Bardel B, Lefaucheur JP. Resting-state electroencephalography (EEG) biomarkers of chronic neuropathic pain. A systematic review. Neuroimage. 2022 Sep;258:119351. doi: 10.1016/j.neuroimage.2022.119351. Epub 2022 Jun 2.
- Background: PubMed 28025007Ploner M, Sorg C, Gross J. Brain Rhythms of Pain. Trends Cogn Sci. 2017 Feb;21(2):100-110. doi: 10.1016/j.tics.2016.12.001. Epub 2016 Dec 23.
- Background: PubMed 30260531May ES, Nickel MM, Ta Dinh S, Tiemann L, Heitmann H, Voth I, Tolle TR, Gross J, Ploner M. Prefrontal gamma oscillations reflect ongoing pain intensity in chronic back pain patients. Hum Brain Mapp. 2019 Jan;40(1):293-305. doi: 10.1002/hbm.24373. Epub 2018 Sep 10.
- Background: PubMed 68872Holsheimer J, Feenstra BW. Volume conduction and EEG measurements within the brain: a quantitative approach to the influence of electrical spread on the linear relationship of activity measured at different locations. Electroencephalogr Clin Neurophysiol. 1977 Jul;43(1):52-8. doi: 10.1016/0013-4694(77)90194-8.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Electroencephalography, run by Cleveland Dental Institute 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 6 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 22 Jul 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?
Contact Ulises Carballosa, Resident (7866901609, u.carballosa@cdiohio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception Measurement by EEG. (time frame: January 2024-December 2024). 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 NCT06510244, which also lists 7 linked publications.
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 22 Jul 2024.