Somatosensory Cortical Dynamics in Normal HumansNCT00571051
MEG Study of Mindfulness Based Stress Reduction
A study testing Mindfulness Based Stress Reduction in people with Somatosensory Cortical Dynamics in Normal Humans, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this research is to investigate the effects of mindfulness based stress reduction (MBSR) on measures of brain function. We are looking especially at the ways in which MBSR may affect the way the brain processes the sense of touch. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Somatosensory Cortical Dynamics in Normal Humans
- What is being tested?
- Mindfulness Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- You are eligible to participate in this study because you meet all of our selection criteria:
- You are between ages 18-50
- You are right-handed
- You are able to receive a MRI scan (you have no metal implants or other metal objects or medical devices that would make a MRI scan unsafe for you)
- You are able to follow study instructions and can read and write English
Who cannot join
- You are not eligible to participate in this study if you:
- have any systemic musculoskeletal diseases such as rheumatoid arthritis, systemic lupus, or scleroderma that would affect the function of your nervous system
- have any neurological conditions that might affect your hand, wrist, or arm function
- respond to our questionnaires in a manner suggesting you may be suffering from depression
- are pregnant or a nursing mother
- currently have any ongoing meditation practice, including MBSR.
- are unable to complete our study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to investigate the effects of mindfulness based stress reduction (MBSR) on measures of brain function. We are looking especially at the ways in which MBSR may affect the way the brain processes the sense of touch. The study seeks to recruit healthy, normal adults who are interested in MBSR training, a simple program that involves learning how to pay attention mindfully to the present moment
Read the detailed description
In this study, investigators will randomly assign volunteers to one of two conditions: (1) attend classes to learn MBSR (2) be on a waitlist on which volunteers will continue your activities until the conclusion of the study, at which point they will be offered free MBSR training. The MBSR class and the body scan classes will be videotape-recorded in order to ensure that the instruction meets study standards. Since the videotape will capture your image and voice, you will be identifiable. However, this videotape will only be viewed by HIPAA certified study staff; it will be stored in a locked drawer and will be destroyed 36 months after the completion of the study.
Random assignment works like the flip of a coin. A volunteer has a 1 in 3 chance of receiving MBSR, being asked to continue with his or her normal life, or being asked to practice body scanning. At any time and for any reason at all a volunteer may decide to withdraw from the study. Data about volunteers' experiences, brain structure, and function collected from this study will be stored by investigators at the Osher Institute, Harvard Medical School.
If a volunteer is randomly assigned to receive MBSR, he or she will be asked to attend 8 class sessions of training which will last 2 hours each. He or she will also be asked to attend a 5 hour retreat. In MBSR classes, you will receive instruction in mindfulness based body scan meditation. In addition, a subject assigned to MBSR will receive instruction in sitting meditation and in gentle yoga. Participants in both classes will also be asked to reflect on their meditation experiences during class and will be asked to consider carrying out a home practice during the week, outside of class. MBSR and body scan classes will meet at a meditation class facility convenient to a red line T stop in Cambridge.
Study assessment visits to the Martinos Center facility in Charlestown
In this study, there are 3 study assessment visits to the Martinos Center facility in Charlestown in which volunteers will be asked questions about their daily experience. At all 3 study visits, investigators will also record magnetic field readings of the brain using a non-invasive imaging technique known as magnetoencephalography (MEG). MEG is a technique that measures the small electrical currents produced when cells in the brain are active. This activity is sometimes called "brain waves."
During these recordings, we will also be lightly touching volunteers' left hand and left foot with a plastic knob. We will be asking volunteers to tell us when they think that they can the stimulus.
To help us interpret the MEG magnetic field readings, at a volunteer's first visit we will also use magnetic resonance imaging (MRI) to create an image of his/her brain. MRI is a technique that uses magnetic fields to align the spinning of atoms in water molecules. It then creates an image of the brain and its activity from the tiny amounts of energy released when the atoms relax to their normal state. Structural MRI will give us information about the anatomy of the brain.
At each of the 3 study visits, before a subject begins the brain scans, he/she will be asked to complete two tests. The first test has an assistant lightly press plastic domes on his/her fingertips. The domes have grooves, and he/she will be asked to tell us which way the grooves point. The second test asks him/her to find numbers that will appear on a screen with flashing letters.
Volunteers will also be given questions about daily experience. In addition, at visits 2 and 3, if a subject is assigned to receive MBSR, investigators will ask about experiences with MBSR practice.
Schedule of assessment procedures in visits 1-3:
- Visit 1 involves the following procedures:
- Receiving a magnetic resonance imaging (MRI) brain scan.
- Doing the dome test and numbers test
- Filling out brief questionnaires about activities that performed with the hand, and feelings and experiences in general.
- Undergoing a magnetoencephalography (MEG) recording of brain function.
- Visit 2 involves the following procedures:
- Doing the dome test and numbers test
- Filling out brief questionnaires about feelings and experiences in general and feelings and experiences related to MBSR.
- Undergoing a magnetoencephalography (MEG) recording of brain function.
- Visit 3 involves the following procedures:
- Doing the dome test and numbers test
- Filling out brief questionnaires about feelings and experiences in general and feelings and experiences related to MBSR.
- Undergoing a magnetoencephalography (MEG) recording of brain function.
Each of the 3 study visits to the Martinos Center will last up to 2 hours and 30 minutes.
Optional MBSR class for subjects assigned to waitlist
If a subject is assigned to the waitlist, he/she will have the option of enrolling in a free MBSR class after the completion of study visits to the Martinos Center. This free class will be taught by the chief mindfulness teacher who is a certified MBSR instructor. This free class is offered to only as a courtesy expression of thanks for participating in this study. This free class is not a research study: no research data will be collected in this courtesy class; subjects are free to participate or to refuse to participate in this post-study optional class.
- Being tested
- Mindfulness Based Stress Reduction
- Keywords
- MEG, mindfulness, tactile perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Also called Course is modelled on course taught by Center for Mindfulness, UMASS Worcester. Instructor and lesson plan are certified by Center for Mindfulness
8 week course in mindfulness training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MBSR 8 week course Receives: Behavioral: Mindfulness Based Stress Reduction |
| 2 | No intervention | 8 weeks of natural history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory cortical dynamics
Measured: 8 weeks
Secondary outcomes (1)
Rumination; mindfulness; somatosensory evoked potentials; tactile thresholds
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatosensory Cortical Dynamics in Normal HumansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Kerr, Catherine, Harvard Medical School (HMS and HSDM)
- Investigators
- Catherine Kerr, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571051
- Sponsor's protocol ID
- K01AT003459
- Other IDs
- 001
- Status last verified
- Aug 2009
- First submitted
- 7 Dec 2007
- Last updated
- 11 Sep 2019
- Results posted
- No
Publications
Kerr CE, Wasserman RH, Moore CI. Cortical dynamics as a therapeutic mechanism for touch healing. J Altern Complement Med. 2007 Jan-Feb;13(1):59-66. doi: 10.1089/acm.2006.5245.
PubMed 17309379
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEG Study of Mindfulness Based Stress Reduction
- ClinicalTrials.gov ID
- NCT00571051
- Acronym / sponsor ID
- K01AT003459
- Keywords
- MEG, mindfulness, tactile perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Oct 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to investigate the effects of mindfulness based stress reduction (MBSR) on measures of brain function. We are looking especially at the ways in which MBSR may affect the way the brain processes the sense of touch. The study seeks to recruit healthy, normal adults who are interested in MBSR training, a simple program that involves learning how to pay attention mindfully to the present moment
Detailed description
In this study, investigators will randomly assign volunteers to one of two conditions: (1) attend classes to learn MBSR (2) be on a waitlist on which volunteers will continue your activities until the conclusion of the study, at which point they will be offered free MBSR training. The MBSR class and the body scan classes will be videotape-recorded in order to ensure that the instruction meets study standards. Since the videotape will capture your image and voice, you will be identifiable. However, this videotape will only be viewed by HIPAA certified study staff; it will be stored in a locked drawer and will be destroyed 36 months after the completion of the study.
Random assignment works like the flip of a coin. A volunteer has a 1 in 3 chance of receiving MBSR, being asked to continue with his or her normal life, or being asked to practice body scanning. At any time and for any reason at all a volunteer may decide to withdraw from the study. Data about volunteers' experiences, brain structure, and function collected from this study will be stored by investigators at the Osher Institute, Harvard Medical School.
If a volunteer is randomly assigned to receive MBSR, he or she will be asked to attend 8 class sessions of training which will last 2 hours each. He or she will also be asked to attend a 5 hour retreat. In MBSR classes, you will receive instruction in mindfulness based body scan meditation. In addition, a subject assigned to MBSR will receive instruction in sitting meditation and in gentle yoga. Participants in both classes will also be asked to reflect on their meditation experiences during class and will be asked to consider carrying out a home practice during the week, outside of class. MBSR and body scan classes will meet at a meditation class facility convenient to a red line T stop in Cambridge.
Study assessment visits to the Martinos Center facility in Charlestown
In this study, there are 3 study assessment visits to the Martinos Center facility in Charlestown in which volunteers will be asked questions about their daily experience. At all 3 study visits, investigators will also record magnetic field readings of the brain using a non-invasive imaging technique known as magnetoencephalography (MEG). MEG is a technique that measures the small electrical currents produced when cells in the brain are active. This activity is sometimes called "brain waves."
During these recordings, we will also be lightly touching volunteers' left hand and left foot with a plastic knob. We will be asking volunteers to tell us when they think that they can the stimulus.
To help us interpret the MEG magnetic field readings, at a volunteer's first visit we will also use magnetic resonance imaging (MRI) to create an image of his/her brain. MRI is a technique that uses magnetic fields to align the spinning of atoms in water molecules. It then creates an image of the brain and its activity from the tiny amounts of energy released when the atoms relax to their normal state. Structural MRI will give us information about the anatomy of the brain.
At each of the 3 study visits, before a subject begins the brain scans, he/she will be asked to complete two tests. The first test has an assistant lightly press plastic domes on his/her fingertips. The domes have grooves, and he/she will be asked to tell us which way the grooves point. The second test asks him/her to find numbers that will appear on a screen with flashing letters.
Volunteers will also be given questions about daily experience. In addition, at visits 2 and 3, if a subject is assigned to receive MBSR, investigators will ask about experiences with MBSR practice.
Schedule of assessment procedures in visits 1-3:
- Visit 1 involves the following procedures:
- Receiving a magnetic resonance imaging (MRI) brain scan.
- Doing the dome test and numbers test
- Filling out brief questionnaires about activities that performed with the hand, and feelings and experiences in general.
- Undergoing a magnetoencephalography (MEG) recording of brain function.
- Visit 2 involves the following procedures:
- Doing the dome test and numbers test
- Filling out brief questionnaires about feelings and experiences in general and feelings and experiences related to MBSR.
- Undergoing a magnetoencephalography (MEG) recording of brain function.
- Visit 3 involves the following procedures:
- Doing the dome test and numbers test
- Filling out brief questionnaires about feelings and experiences in general and feelings and experiences related to MBSR.
- Undergoing a magnetoencephalography (MEG) recording of brain function.
Each of the 3 study visits to the Martinos Center will last up to 2 hours and 30 minutes.
Optional MBSR class for subjects assigned to waitlist
If a subject is assigned to the waitlist, he/she will have the option of enrolling in a free MBSR class after the completion of study visits to the Martinos Center. This free class will be taught by the chief mindfulness teacher who is a certified MBSR instructor. This free class is offered to only as a courtesy expression of thanks for participating in this study. This free class is not a research study: no research data will be collected in this courtesy class; subjects are free to participate or to refuse to participate in this post-study optional class.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Mindfulness Based Stress ReductionMBSR 8 week course |
| 2 | No intervention | –8 weeks of natural history |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- -
- You are eligible to participate in this study because you meet all of our selection criteria:
- You are between ages 18-50
- You are right-handed
- You are able to receive a MRI scan (you have no metal implants or other metal objects or medical devices that would make a MRI scan unsafe for you)
Key exclusion criteria (7 listed)
- You are not eligible to participate in this study if you:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress ReductionAlso: Course is modelled on course taught by Center for Mindfulness, UMASS Worcester. Instructor and lesson plan are certified by Center for Mindfulness8 week course in mindfulness training | Behavioural | 1 |
Primary outcome
Somatosensory cortical dynamics
Time frame: 8 weeks
1 secondary outcome
Rumination; mindfulness; somatosensory evoked potentials; tactile thresholds
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 17309379Kerr CE, Wasserman RH, Moore CI. Cortical dynamics as a therapeutic mechanism for touch healing. J Altern Complement Med. 2007 Jan-Feb;13(1):59-66. doi: 10.1089/acm.2006.5245.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Kerr, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction in people with Somatosensory Cortical Dynamics in Normal Humans, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory cortical dynamics (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.