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Actigraphic Measurement of a Neurosurgical Procedure

Sponsor
Child Psychopharmacology Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00945230
Collaborator
Mayo Clinic (Other)
1
Enrollment
1
Location
1
Arm
3
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Re-section of a large left anterior cranial fossa meningioma
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
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
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Actigraphy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pre and Post Actigraphic and Systematic Observation Scale measurements [March 15, 2009-June 20, 2009]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of incidental meningioma

    • Single subject preparing to receive neurosurgical intervention

    Exclusion Criteria:
    • Inability to wear actigraphy device

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00945230
    Other Study ID Numbers:
    • Act2NS
    First Posted:
    Jul 24, 2009
    Last Update Posted:
    Jul 24, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    Neurosurgical outcome
    Actigraphy
    Treatment Response Measurement
    Additional relevant MeSH terms:
    Sleep Wake Disorders

    Study Results

    No Results Posted as of Jul 24, 2009