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NCT00945230 Clinical Trial

Actigraphic Measurement of a Neurosurgical Procedure

Pain Clinical Trial

Official title:
Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00945230
Other study ID # Act2NS
Secondary ID
Status Completed
Phase N/A
First received July 23, 2009
Last updated July 23, 2009
Start date March 2009
Est. completion date June 2009

Study information
Verified date July 2009
Source Child Psychopharmacology Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosis of incidental meningioma

- Single subject preparing to receive neurosurgical intervention

Exclusion Criteria:

- Inability to wear actigraphy device

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Procedure:
• Re-section of a large left anterior cranial fossa meningioma
Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma

Locations
Country Name City State
United States Child Psychopharmacology Institute Fargo North Dakota

Sponsors (2)
Lead Sponsor Collaborator
Child Psychopharmacology Institute Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pre and Post Actigraphic and Systematic Observation Scale measurements March 15, 2009-June 20, 2009 No
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