Back to resultsNeural Correlates of Acute Pain Dynamics
Primary Purpose
Pain
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Pain focused on measuring Mesolimbic system, Dopamine circuits, Psychophysics
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: Pregnant History of chronic pain History of neurological diagnosis History of psychiatric diagnosis
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylphenidate
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Effect of methylphenidate on acute pain dynamics
We will compare acute pain dynamics-i.e., the time series of pain visual analog scale ratings (0-100, where 0 = no pain and 100 = worst pain imaginable) obtained while delivering a changing noxious stimulus-during the methylphenidate condition to that of the placebo condition.
Nucleus accumbens activation with acute pain dynamics
We will regress the time course of nucleus accumbens BOLD activity onto the latent time series obtained from our valence competition model. This will be supported by regressing the nucleus accumbens time course onto the pain VAS time course, allowing our findings to be compared to standard analyses in the literature.
Secondary Outcome Measures
Full Information
NCT ID
NCT05669924
First Posted
December 20, 2022
Last Updated
March 28, 2023
Sponsor
Northwestern University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT05669924
Brief Title
Neural Correlates of Acute Pain Dynamics
Official Title
The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Mesolimbic system, Dopamine circuits, Psychophysics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
0.35 mg/kg methylphenidate will be administered after baseline testing and 45 min-1 hr before post-intervention testing.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for methylphenidate
Primary Outcome Measure Information:
Title
Effect of methylphenidate on acute pain dynamics
Description
We will compare acute pain dynamics-i.e., the time series of pain visual analog scale ratings (0-100, where 0 = no pain and 100 = worst pain imaginable) obtained while delivering a changing noxious stimulus-during the methylphenidate condition to that of the placebo condition.
Time Frame
6 months
Title
Nucleus accumbens activation with acute pain dynamics
Description
We will regress the time course of nucleus accumbens BOLD activity onto the latent time series obtained from our valence competition model. This will be supported by regressing the nucleus accumbens time course onto the pain VAS time course, allowing our findings to be compared to standard analyses in the literature.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
Pregnant
History of chronic pain
History of neurological diagnosis
History of psychiatric diagnosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew D Vigotsky, MS
Phone
3125032562
Email
vigotsky@u.northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Vigotsky, MS
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew D Vigotsky, MS
Phone
312-503-2562
Email
vigotsky@u.northwestern.edu
First Name & Middle Initial & Last Name & Degree
A. Vania Apkarian, PhD
First Name & Middle Initial & Last Name & Degree
Alyson Engle, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be anonymized and shared on OpenPain.org upon publication.
IPD Sharing Time Frame
1 year
Learn more about this trial
Neural Correlates of Acute Pain Dynamics
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