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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01629914
Other study ID # Pro00037192
Secondary ID
Status Withdrawn
Phase N/A
First received June 26, 2012
Last updated January 30, 2017
Start date June 2012
Est. completion date January 2013

Study information

Verified date January 2013
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.


Description:

The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in executive brain functioning prior to and following an 8-week, group-based mindfulness meditation intervention within a group of 10 adults diagnosed with Attention-deficit/hyperactivity disorder (ADHD). Another group of 10 adults diagnosed with ADHD will be placed in the waitlist condition.

Our primary hypothesis is that adults with ADHD in the treatment group will exhibit improved performance on a series of executive functioning tasks and that exposure to task stimuli will correspond to changes in neural functioning following an 8-week, group-based mindfulness intervention. Brain responses will be measured using blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with emotional and executive processes prior to and following treatment.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- ages 18-50 years

- meet DSM-IV criteria for ADHD

- intellectual functioning = 80 as assessed by an IQ screener

- generally healthy (i.e., no major medical problems)

Exclusion Criteria:

- major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant), uncomfortable (e.g., chronic pain)

- claustrophobic, or abnormally afraid of closed-in places

- current drug use

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Behavioral:
Mindfulness Meditation
8-week, group-based mindfulness meditation intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal Participants will be scanned prior to and following an 8-week group-based mindfulness meditation intervention baseline and 8-weeks
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