- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983930
Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this pilot study intervention is to investigate brain mechanisms of response to memory enhancement training (MET) compared to Kundalini yoga and "Kirtan Kriya" meditation using functional magnetic resonance imaging (fMRI) that will be acquired from each subject at baseline and at 12 weeks (post-randomization).
Overall, the investigators anticipate recruiting 66 adults with memory complaints and diagnosed with MCI for adults 55 years old and older. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week. All assessments will be completed immediately after the interventions for a total of 10 visits in 12 weeks and a follow-up visit at 6 months (24 weeks)to monitor the overall benefit of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Semel Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mild cognitive impairment amnestic type
- Clinical Dementia Rating scale score of 0.5
- SufficientEnglish proficiency and 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV
- Capacity to provide informed consent.
Exclusion criteria:
- Any current or past psychiatric disorders, or recent unstable medical or neurological disorders
- Any disabilities preventing their participation in the memory enhancement training (MET) (e.g. severe visual or hearing impairment)
- Insufficient English proficiency
- Diagnosis of dementia
- Mini Mental Health Examination score of 24 and below
- Psychoactive medications
- Participation in a psychotherapy that involves cognitive training
- Do not meet criteria for Mild cognitive impairment subtype
- Prior or current training in yoga.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Memory Training
Group memory training will be administered for amnestic mild cognitive impairment (MCI)
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Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.
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Experimental: Kundalini yoga and meditation
Participants will engage in weekly yoga classes and daily 20 minute meditation
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Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score
Time Frame: At baseline and at 6 months
|
Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning.
Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores.
The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials.
When scoring the HVLT, the three learning trials are combined to calculate a total recall score.
Total scores range from 0-36 with higher scores indicating better outcome.
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At baseline and at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Global Impression Scale
Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 24
|
The CGI measures severity of illness and global improvement.
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
CGI global improvement scores range from 1 (very much improved) through to 7 (very much worse).
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Baseline, weeks 2, 4, 6, 8, 10, 12, 24
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Geriatric Depression Scale (GDS)
Time Frame: Baseline and Week 24
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Secondary outcomes measures included mood assessments with the GDS, a self-assessment scale often used in geriatric depression trials.
The GDS is a 30-item screening tool used to identify depression in older adults.
In scoring the Geriatric Depression Scale, each item is scored 0 or 1.
The total score on the scale ranges from 0 to 30 with higher scores indicating worse outcome.
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Baseline and Week 24
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Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity
Time Frame: Baseline and week 12
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FMRI scans will be obtained at baseline and after 12 weeks follow up.
Default mode network findings were analyzed and significant effects were identified for yoga and memory enhancement training groups.
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Baseline and week 12
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Collaborators and Investigators
Investigators
- Principal Investigator: Helen Lavretsky, MD, MS, UCLA Semel Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cognitive Dysfunction
- Memory Disorders
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Neurological Rehabilitation
- Relaxation Therapy
- Cognitive Training
- Meditation
Other Study ID Numbers
- 13-000821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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