Peripheral Neuroimmune Mechanisms of Hyperthermia
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT05366270
- Status
- Recruiting
Conditions
- Hyperthermia
- Inflammation
- Major Depressive Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- WBH — DEVICEHyperthermia exposure using Heckel Hyperthermia Device
- Sham — DEVICESham (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: ShamUnder 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
- Simmie Foster, MD PhD617-643-7427
- Maren Nyer, PhD617-643-4897
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital Depression Clinical & Research Program | Boston | Massachusetts | 02114 | Simmie Foster, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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