Neural Correlates of Acute Pain Dynamics

NCT05669924 | Completed Phase 2 FDA Drug

• 1 other identifier: STU00213557
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.

Conditions

Pain

Keywords

Mesolimbic system; Dopamine circuits; Psychophysics

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methylphenidate DRUG

0.35 mg/kg methylphenidate will be administered after baseline testing and 45 min-1 hr before post-intervention testing.

Methylphenidate

Placebo DRUG

Placebo for methylphenidate

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnant
• History of chronic pain
• History of neurological diagnosis
• History of psychiatric diagnosis

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrew D Vigotsky, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: September 19, 2022
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: 1 year

Locations

US (1)