NCT00945230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

July 23, 2009

Last Update Submit

July 23, 2009

Conditions

Sleep DisordersCircadian RhythmPainRehabilitationMood Lability

Keywords

Neurosurgical outcomeActigraphyTreatment Response Measurement

Outcome Measures

Primary Outcomes (1)

  • Pre and Post Actigraphic and Systematic Observation Scale measurements

    March 15, 2009-June 20, 2009

Study Arms (1)

Actigraphic Neurosurgical Outcomes

EXPERIMENTAL

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

Interventions

Re-section of a large left anterior cranial fossa meningiomaPROCEDURE

Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma

Also known as: Actigraphy
Actigraphic Neurosurgical Outcomes

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to wear actigraphy device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Psychopharmacology Institute

Fargo, North Dakota, 58103, United States

Location

MeSH Terms

Conditions

Sleep Wake DisordersPain

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisAccelerometryInvestigative Techniques

Study Officials

  • Bill J Duke, M.A., Ph.D.

    Child Psychopharmacology Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations

US(1)