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Actigraphic Measurement of a Neurosurgical Procedure

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Child Psychopharmacology Institute
ClinicalTrials.gov Identifier:
NCT00945230
First received: July 23, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 23, 2009
Last Updated: July 23, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013