Massage: Neuroimaging and Correlates of Response - 1-week Study

Not Applicable

Active, not recruiting

• Conditions: Healthy Participants

• Registration Number: NCT07190313
• Lead Sponsor: University of Utah

Brief Summary

This study will compare the effects (good or bad) of Swedish massage or light touch therapy on your brain activity, physical responses (like heart rate, blood pressure, breathing rate), and mood and stress. This is a randomized research study. "Randomized" means that participants will be assigned to a study group by chance, like flipping a coin. Participants will be randomized into one of two study groups, and will have an equal chance of being placed in one of the groups: - A single session of Swedish massage therapy - A single session of Light touch therapy At the study visit, the study staff ask about life stressors, medical health, medicine use, and illicit substance use over the past week. The study uses magnetic resonance imaging (MRI) as well as functional MRI (fMRI) to look at the structure and activation of the brain. Participants will undergo two brain scanning sessions, one immediately before and one immediately after the Swedish massage or light touch therapy. The scans will last approximately 45 minutes. During the brain scanning sessions, information on heart rate, blood pressure, temperature and breathing will also be collected.

Detailed Description

This is a two-arm, randomized, single masked study investigating the effects of a single session of Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects. The Primary Objective is to identify brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the neutral/fearful/angry faces task in normal control subjects. The secondary objective is to correlate changes in autonomic measures with resting state fMRI.

Study Timeline

• Study Start: 2024-04-24
• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-02
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female
• aged ≥ 18 and < 65 years old.
• Medically stable
• Psychiatrically healthy as demonstrated by a structured clinical interview that elicits no previous or current Axis I psychopathology
• Ability to lie prone or supine for one hour at a time, given the nature of the massage intervention
• Subjects must have a permanent domicile
• Subjects must be able to comply with the research protocol
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria

• Current (within 3 months of screening visit) nicotine use, illicit drug use, or long-term medication use that, in the opinion of the investigator, could alter the results of the study
• Pregnancy (per participant report, pregnancy testing not done for study)
• Usually is asleep during the daytime (ie due to Working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms
• Current (past month) rigorous dieting (defined as <1200 calories per day for ≥2 consecutive days)
• In the month before screening visit, excessive regular use of alcohol, as defined by either of the following, twice a month or more often: (a drink is one 5 ounce glass of wine or equivalent) a. ingestion of 5 drinks or more in a 2 hour period b. ingestion of 7 drinks or more in a 24 hour period
• At screening visit, CURRENTLY using any of the following interventions because of psychological distress (for example, for treatment of anxiety and/or other psychiatric condition). (These types of treatments are also prohibited during the study period.) a. participating in psychotherapy b. participating in CAM (complementary and alternative medical interventions) c. taking medication(s) (for example anxiolytics, antidepressants, and other psychotropic medications)
• Participant meets criteria for current suicidal or homicidal ideation
• Subjects who have massages on a regular basis. Regular massage usage will be defined as receiving on average 4 or more massages/year for the last 5 years
• Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem
• History of head injury or neurological disorder, that in the investigator's opinion would impact the data or preclude safe and successful completion of the study. - History of cancer that required chemotherapy and/or radiation treatment
• General contraindication to MRI - Because MRI uses a very strong magnet, subjects cannot have metals in their bodies or certain medical conditions. Subjects cannot have a cardiac pacemaker; hearing aid; any other implant metal in their body or eyes, including pins, screws, shrapnel, plates, teeth braces, or dentures. Subjects cannot have tattoos on their head, such as eyeliner or other permanent makeup, as they may make it impossible to get clear and usable images
• Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study
• Current participation in another research study (excluding large natural cohort trials such as 'All of Us')

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in resting state functional connectivity during fMRI	Day 1	Resting state functional connectivity during fMRI will be evaluated immediately before and immediately after a single session of SMT or LT in healthy non-psychiatric control subjects.

Secondary Outcome Measures

Name	Time	Method
Change in connectivity in response to fearful/angry faces task	Day 1	Neuronal connectivity in response to neutral/fearful/angry faces task during fMRI will be evaluated immediately before and immediately after a single session of SMT or LT in healthy non-psychiatric control subjects.
Autonomic activity (heart rate variability, heart rate, pulse)	Day 1	Correlation of change in autonomic measures (heart rate variability, heart rate, pulse) with resting state functional connectivity and neuronal activation in response to fearful/angry faces task during fMRI will be determined immediately before and immediately after a single session of SMT or LT in healthy non-psychiatric control subjects.

Trial Locations

Locations (1)

Huntsman Mental Health Institute; 🇺🇸 Salt Lake City, Utah, United States