Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma
| Registry | NCT00945230 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, health services research |
| Enrollment | 1 (Actual) |
| Sponsor | Child Psychopharmacology Institute (Other); collaborators: Mayo Clinic |
| Conditions | Sleep Disorders, Circadian Rhythm, Pain, Rehabilitation, Mood Lability |
| Interventions | Re-section of a large left anterior cranial fossa meningioma (Procedure) |
| Dates | start 2009-03-01, primary completion 2009-06-01, completion 2009-06-01, first posted 2009-07-24, last updated 2009-07-24 |
| Locations | 1 site in United States |
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The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Actigraphic Neurosurgical Outcomes | Experimental | Procedure: 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. |
Sex: Female, ages: 21 Years to 75 Years
Inclusion Criteria: * Diagnosis of incidental meningioma * Single subject preparing to receive neurosurgical intervention Exclusion Criteria: * Inability to wear actigraphy device
| Facility | City | Country | Status |
|---|---|---|---|
| Child Psychopharmacology Institute | Fargo, North Dakota | United States |