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Actigraphic Measurement of a Neurosurgical Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945230
First Posted: July 24, 2009
Last Update Posted: July 24, 2009
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. Read our disclaimer for details.
Collaborator:
Mayo Clinic
Information provided by:
Child Psychopharmacology Institute
  Purpose
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Condition Intervention
Sleep Disorders Circadian Rhythm Pain Rehabilitation Mood Lability Procedure: Re-section of a large left anterior cranial fossa meningioma

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma

Resource links provided by NLM:


Further study details as provided by Child Psychopharmacology Institute:

Primary Outcome Measures:
  • Pre and Post Actigraphic and Systematic Observation Scale measurements [ Time Frame: March 15, 2009-June 20, 2009 ]

Enrollment: 1
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Actigraphic Neurosurgical Outcomes
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.
Procedure: Re-section of a large left anterior cranial fossa meningioma
Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma
Other Name: Actigraphy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of incidental meningioma
  • Single subject preparing to receive neurosurgical intervention

Exclusion Criteria:

  • Inability to wear actigraphy device
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00945230


Locations
United States, North Dakota
Child Psychopharmacology Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Child Psychopharmacology Institute
Mayo Clinic
Investigators
Principal Investigator: Bill J Duke, M.A., Ph.D. Child Psychopharmacology Institute
  More Information

Responsible Party: Bill J. Duke, M.A., Ph.D., ABMPP, Child Psychopharmacology Institute
ClinicalTrials.gov Identifier: NCT00945230     History of Changes
Other Study ID Numbers: Act2NS
First Submitted: July 23, 2009
First Posted: July 24, 2009
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Child Psychopharmacology Institute:
Neurosurgical outcome
Actigraphy
Treatment Response Measurement

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders