Healthy Controls
Conditions
Brief summary
Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of (\[11C\]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study.
Interventions
RADIATIONPET imaging
Up to a 120 minute PET scan using \[11C\]diprenorphine as the radiotracer
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female adults, 21 to 50 years of age * No contraindications to fMRI and PET scanning * Within 15% of ideal body mass index (BMI)
Exclusion criteria
* Current significant medical, neurological, or psychiatric illness as assessed by the Physician Investigators * Women who are pregnant or breast feeding, have gone through menopause, and/or have irregular menstrual cycles * Claustrophobia * History of head trauma * Instability of responses to experimental pain (See Study Procedure Section Part II) * History of asthma * Use of psychotropic drugs or hormone treatments (including hormonal birth control) within one year of date of consent * History of smoking * Routine exercise in excess of one hour per day and/or three times per week * Non-fluent English speaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET/MRI Brain Activation | day one | Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure. The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. The additional scan session for subjects will be performed under no pain, control conditions. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | could not tolerate long scan duration | 3 |
Baseline characteristics
| Characteristic | Healthy Volunteers |
|---|---|
| Age, Continuous | 24.1 years STANDARD_DEVIATION 2.7 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
PET/MRI Brain Activation
Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure. The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change.
Time frame: day one
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls | PET/MRI Brain Activation | 0.21 percentage BOLD signal change | Standard Deviation 0.13 |