Quantitation of Glymphatic Functioning in Sleep and Meditative States
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04506892|
Recruitment Status : Not yet recruiting
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Sleep||Behavioral: Meditation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Quantitation of Glymphatic Functioning in Sleep and Meditative States|
|Estimated Study Start Date :||July 2021|
|Estimated Primary Completion Date :||July 2026|
|Estimated Study Completion Date :||July 2027|
Experimental: Meditation Class
Subjects will undergo an intervention involving meditation classes for 2.5 hours a week for 8 weeks between pre- and post-class MRI
Meditation classes will help to improve clinical health and well-being, as well as reduce stress.
- CSF flow change [ Time Frame: baseline to 8 weeks ]Using MRI to assess the change in CSF flow before and after intervention
- EEG changes [ Time Frame: baseline to 8 weeks ]Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.
- Hospital Anxiety and Depression Scale [ Time Frame: baseline to 8 weeks ]Looking at behavioral correlates (i.e. anxiety, depression) associated with before and after intervention. There are 2 parts, Anxiety, where the lowest score would be a 0 and the highest is 21, and the higher a score is, the more anxious behaviors there are. The second part is a depressive behavior scale, which the lowest score is 0, and the highest is 21, and the higher the score, the more depressive behaviors there are.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506892
|Contact: Daniel Claassen, MDfirstname.lastname@example.org|
|Contact: Ciaran Considine, PhDemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212-3160|
|Principal Investigator:||Daniel Claassen, MD||Vanderbilt University Medical Center|