Actigraphic Measurement of a Neurosurgical Procedure

Not Applicable

Completed

• Conditions: Sleep Disorders; Circadian Rhythm; Pain; Rehabilitation; Mood Lability
• Interventions: Procedure: Re-section of a large left anterior cranial fossa meningioma

• Registration Number: NCT00945230
• Lead Sponsor: Child Psychopharmacology Institute

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Last Update Submitted: 2009-07-23
• Study First Posted: 2009-07-24
• Last Update Posted: 2009-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

• Inability to wear actigraphy device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Actigraphic Neurosurgical Outcomes	Re-section of a large left anterior cranial fossa meningioma	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.

Primary Outcome Measures

Name	Time	Method
Pre and Post Actigraphic and Systematic Observation Scale measurements	March 15, 2009-June 20, 2009

Trial Locations

Locations (1)

Child Psychopharmacology Institute; 🇺🇸 Fargo, North Dakota, United States