Back to resultsActigraphic Measurement of a Neurosurgical Procedure
Primary Purpose
Sleep Disorders, Circadian Rhythm, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Re-section of a large left anterior cranial fossa meningioma
Sponsored by
About this trial
This is an interventional health services research trial for Sleep Disorders focused on measuring Neurosurgical outcome, Actigraphy, Treatment Response Measurement
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of incidental meningioma
- Single subject preparing to receive neurosurgical intervention
Exclusion Criteria:
- Inability to wear actigraphy device
Sites / Locations
- Child Psychopharmacology Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Actigraphic Neurosurgical Outcomes
Arm Description
Actigraphic measurements that will be obtained by attaching the actigraphic watch device to the individual's non-dominant wrist and operationally defined repeated observational measurements. All measurements will continue through a baseline period and continue through the identified post surgical period. Actigraphic measurements will occur every 30 seconds with brief periods of non-measurement during the actual neurosurgical procedure and periods when the actigraphic device has reached storage capacity (approximately every 22 days) when data is retrieved and the device prepared resume measurements.
Outcomes
Primary Outcome Measures
Pre and Post Actigraphic and Systematic Observation Scale measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT00945230
First Posted
July 23, 2009
Last Updated
July 23, 2009
Sponsor
Child Psychopharmacology Institute
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00945230
Brief Title
Actigraphic Measurement of a Neurosurgical Procedure
Official Title
Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Child Psychopharmacology Institute
Collaborators
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Detailed Description
Actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat MRI is completed three months after the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm, Pain, Rehabilitation, Mood Lability
Keywords
Neurosurgical outcome, Actigraphy, Treatment Response Measurement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Actigraphic Neurosurgical Outcomes
Arm Type
Experimental
Arm Description
Actigraphic measurements that will be obtained by attaching the actigraphic watch device to the individual's non-dominant wrist and operationally defined repeated observational measurements. All measurements will continue through a baseline period and continue through the identified post surgical period. Actigraphic measurements will occur every 30 seconds with brief periods of non-measurement during the actual neurosurgical procedure and periods when the actigraphic device has reached storage capacity (approximately every 22 days) when data is retrieved and the device prepared resume measurements.
Intervention Type
Procedure
Intervention Name(s)
Re-section of a large left anterior cranial fossa meningioma
Other Intervention Name(s)
Actigraphy
Intervention Description
Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma
Primary Outcome Measure Information:
Title
Pre and Post Actigraphic and Systematic Observation Scale measurements
Time Frame
March 15, 2009-June 20, 2009
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of incidental meningioma
Single subject preparing to receive neurosurgical intervention
Exclusion Criteria:
Inability to wear actigraphy device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill J Duke, M.A., Ph.D.
Organizational Affiliation
Child Psychopharmacology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Psychopharmacology Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Actigraphic Measurement of a Neurosurgical Procedure
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