Clinical trial NCT00723580: Actigraphic Analysis of Treatment Response
Official title: Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorders, Circadian Rhythm
Insomnia
Psychomotor Agitation
Keywords: Kabuki Syndrome
Actigraphy
Treatment Response Measurement
Lead sponsor: Child Psychopharmacology Institute
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 1
Sex: FEMALE
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. The non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. Meaningful treatment response measurements are obtained when actigraphic data is combined with psychometric and observational repeated measurements. Subsequent to the initial data collection the parent consented and the child assented to extend the study and continue measurements.

The case study included baseline and repeated psychological, observational and actigraphic measurements that were initiated prior to treatment with risperidone and repeated throughout the treatment process with the final data collected in July 2010.

The Personality Inventory for Children (PIC) is an objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment associated change.

A primary observer (mother) was trained to report symptom percentages present since previous observations utilizing the operationally defined and observer defined items of the systematic observation scale throughout the treatment process.

Actigraphic measurements provide a basis by which to measure sleep and sleep onset latency as well as periods of mobility and immobility. When programmed to record activity every thirty seconds, thousands of measurements are quickly captured.

Actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day baseline actigraphic measurement period and continued measurements that included the initiation of a Once-Daily, Bedtime (q.h.s.) pharmacological intervention for 6 days, followed by a planned adjustment to Twice a Day (b.i.d.) dosing that was measured for an additional 4 days. Repeated actigraphic studies were subsequently conducted after 22 months of risperidone treatment and were collected along with the repeated observational and psychometric data.

This case study explores activity and sleep characteristics related to behavioral characteristics and treatment response and the utility of single subject repeated actigraphic, psychometric and observational measurements and monitoring of treatment response.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Kabuki Syndrome
* Medication Naive
* Single subject preparing to receive pharmacological intervention

Exclusion Criteria:

* Inability to wear actigraphy device

Primary outcomes:
measure: Actigraphic Measurement of Treatment Conditions
timeFrame: May 12- July 14, 2010
Secondary outcomes:
measure: Systematic Observation Scale Item: Percentage of Impulsivity Observed
timeFrame: May-7-2008 to July -14-2010
measure: Systematic Observation Scale: Percentage of Irritability Observed
timeFrame: May-7-2008 to July -14-2010
measure: Systematic Observation Scale: Percentage of Distractibility Observed
timeFrame: May-7-2008 to July -14-2010
measure: Systematic Observation Scale: Percentage of Hyperactivity Observed
timeFrame: May-7-2008 to July -14-2010
measure: The Personality Inventory for Children: Adjustment Scale
timeFrame: May-7-2008 to July -14-2010
measure: The Personality Inventory for Children: Achievement Scale
timeFrame: May-7-2008 to July -14-2010
measure: The Personality Inventory for Children: Somatic-Physiological Scale
timeFrame: May-7-2008 to July -14-2010
measure: The Personality Inventory for Children: Delinquency Scale
timeFrame: May 7, 2008-July 14,2010
measure: The Personality Inventory for Children: Withdrawal Scale
timeFrame: May-7-2008 to July -14-2010
measure: The Personality Inventory for Children: Social Skills Scale
timeFrame: May-7-2008 to July -14-2010
measure: The Personality Inventory for Children: Family Relations Scale
timeFrame: May-7-2008 to July -14-2010
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Child Psychopharmacology Institute
state: North Dakota
Study officials:
affiliation: Child Psychopharmacology Institute
name: Bill J Duke, M.A., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: