Peripheral Neuroimmune Mechanisms of Hyperthermia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05366270
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • WBH — DEVICE
    Hyperthermia exposure using Heckel Hyperthermia Device
  • Sham — DEVICE
    Sham (mild heating) using Heckel Hyperthermia Device

Study Details

The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.

Key Dates

Start date
Nov 1, 2022
Status verified
Mar 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Whole Body Hyperthermia (WBH)
    A single treatment of Whole Body Hyperthermia will be administered using the Heckel Hyperthermia device. During this procedure, participants' core body temperature will be elevated to 38.5 degrees Celsius.
  • Sham Comparator: Sham
    Under the sham condition, participants will enter the Heckel Hyperthermia device as in the active treatment condition, but will not receive the whole body hyperthermia treatment, and will instead only receive mild heating.

Primary Outcome Measure

Changes in serum levels of Interleukin-6 from baseline to post-treatment [ Time Frame: baseline (pre-intervention), one hour post-intervention, 24 hours post-intervention, one week post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Depression Clinical & Research ProgramBostonMassachusetts02114
Study Coordinator
617-724-3222
Simmie Foster, MD, PhD (PRINCIPAL_INVESTIGATOR)

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