Clinical TrialID 7479
The Role of Brain Dopamine in Chronic Pain
NCT05285683
Chronic Pain
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7479
- Evidence Id
- 7479
- Core Evidence Id
- 7479
- Source Clinical Trial Id
- 7474
- Herb2 Clinical Trial Id
- HBCT007474
- Nct Id
- NCT05285683
- Title
- The Role of Brain Dopamine in Chronic Pain
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Chronic Pain
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Methylphenidate|DRUG: carbidopa-levodopa|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 10
- Outcome Measure
- mean change in amygdala volume, Amygdala volume will be measured using T1w MPRAGE structural images. The mean change in amygdala volume will be the volume of amygdala before administering the drug or placebo minus the volume of amygdala after administering the drug or placebo., baseline to 3 hours|mean change in hippocampus volume, Hippocampus volume will be measured using T1w MPRAGE structural images. The mean change in hippocampus volume will be the volume of hippocampus before administering the drug or placebo minus the volume of hippocampus after administering the drug or placebo., baseline to 3 hours|mean change in thalamus volume, Thalamus volume will be measured using T1w MPRAGE structural images. The mean change in thalamus volume will be the volume of thalamus before administering the drug or placebo minus the volume of thalamus after administering the drug or placebo., baseline to 3 hours|mean change in Nucleus accumbens volume, Nucleus accumbens volume will be measured using T1w MPRAGE structural images. The mean change in Nucleus accumbens volume will be the volume of Nucleus accumbens before administering the drug or placebo minus the volume of Nucleus accumbens after administering the drug or placebo., baseline to 3 hours|mean change in amygdala activity, Amygdala activity will be determined using Blood Oxygen Level Dependent (BOLD) fMRI sequences. The mean change in amygdala activity will be the activity of amygdala before administering the drug or placebo minus the activity of amygdala after administering the drug or placebo., baseline to 3 hours|mean change in hippocampus activity, Hippocampus activity will be determined using Blood Oxygen Level Dependent (BOLD) fMRI sequences. The mean change in hippocampus activity will be the activity of hippocampus before administering the drug or placebo minus the activity of hippocampus after administering the drug or placebo., baseline to 3 hours|mean change in thalamus activity, Thalamus activity will be determined using Blood Oxygen Level Dependent (BOLD) fMRI sequences. The mean change in thalamus activity will be the activity of thalamus before administering the drug or placebo minus the activity of thalamus after administering the drug or placebo., baseline to 3 hours|mean change in Nucleus Accumbens activity, Nucleus Accumbens activity will be determined using Blood Oxygen Level Dependent (BOLD) fMRI sequences. The mean change in Nucleus Accumbens activity will be the activity of Nucleus Accumbens before administering the drug or placebo minus the activity of Nucleus Accumbens after administering the drug or placebo., baseline to 3 hours
- Sponsor Collaborator
- University of Rochester
- Funded By
- OTHER
- Location
- University of Rochester Medical Center, Rochester, New York, 14642, United States
- Other Id
- STUDY00006948
- Start Date
- 2024-02-02
- Primary Completion Date
- 2024-12-22
- Completion Date
- 2025-01-22
- First Posted
- 2022-03-17
- Results First Posted
- Last Update Posted
- 2024-04-04
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05285683
- Title Cn
- Title En
- The Role of Brain Dopamine in Chronic Pain
- Bilingual Status
- semi_complete