- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937897
Unilateral Massage as a Potential Treatment for Depression
February 3, 2014 updated by: University of Arizona
In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the left hemisphere.
In this study a moderate pressure massage will be conducted by a trained professional on one of the following conditions: the right side of the body, the left side of the body, or both sides of the body (a traditional massage on the back of the body) while EEG measurements of brain activity are recorded and mood ratings are obtained.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Medically and mentally healthy, right-handed participants will be eligible for participating in this study. The age range for enrollment in the study is not restricted by any variables but will be set between 18 and 50 years of age.
Exclusion Criteria:
- Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Left-Sided Massage
Unilateral massage on the left side of the body.
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Unilateral massage on the left side of the body.
Other Names:
|
Active Comparator: Right-Sided Massage
Unilateral massage on the right side of the body.
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Unilateral massage on the left side of the body.
Other Names:
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Sham Comparator: Bi-Lateral Massage
Traditional massage on the back of the body.
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Unilateral massage on the left side of the body.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-invasive EEG recording
Time Frame: Collected 4 minutes after the unilateral massage has ended.
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EEG recording using an electrode cap and electrode gel connected to an EEG Machine to record brain activity.
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Collected 4 minutes after the unilateral massage has ended.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PANAS (Postitive and Negative Affect Schedule)Questionnaire
Time Frame: Collected immediately following the unilateral massage.
|
To obtain mood ratings before and after the UMI.
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Collected immediately following the unilateral massage.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles Raison, MD, University of Arizona
- Principal Investigator: Clemens Janssen, MS, University of Arizona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
August 30, 2013
First Submitted That Met QC Criteria
September 4, 2013
First Posted (Estimate)
September 10, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2014
Last Update Submitted That Met QC Criteria
February 3, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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