Instrumented Data Exchange for Ataxia Study

Friedreich Ataxia Clinical Trial

— IDEA  

Official title:

APDM Instrumented Data Exchange for Ataxia (IDEA) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04268147
• Other study ID #: IRB18-1580
• Status: Active, not recruiting
• Start date: June 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing

• SCA: aged 18-75 years

• FA: aged 12-30, diagnosed between ages 5-25

• community dwelling

• physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement

• able to walk independently 10 yards without an assistive device

• able to sit or stand unassisted for 30 seconds

• no other neurological or musculoskeletal disorder that could affect mobility

• no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility

• willing and able to participate in a 2-year study

• consent to be video recorded while performing study assessments

Exclusion Criteria:

• dementia that limits subjects' ability to follow directions

• pain that limits mobility

• SCA: enrolled in a clinical drug trial

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Friedreich Ataxia
• Machado-Joseph Disease
• Spinocerebellar Ataxia Type 1
• Spinocerebellar Ataxia Type 2
• Spinocerebellar Ataxia Type 3
• Spinocerebellar Ataxia Type 6
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	Mass General Hospital	Boston	Massachusetts
United States	The University of Chicago	Chicago	Illinois
United States	University of California-Los Angeles	Los Angeles	California
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
University of Chicago	APDM Wearable Technologies, Biogen, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iSARA	measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)	2 years
Primary	SARA	Scale for the Assessment and Rating of Ataxia (SARA) measurements evaluated by clinician to measure severity of spinocerebellar ataxia through coordination, speech, stance, and gait	2 years
Primary	mFARS	modified Friedreich's Ataxia Rating Scale (mFARS) measurements evaluated by clinician compared to measure severity of Friedreich's ataxia through coordination, speech, stance, and gait	2 years
Primary	Daily Life (UChicago site ONLY)	APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects	2 weeks
Primary	Ataxia App on Watch/iPhone	Bi-weekly assessments completed on Ataxia Application for Apple Watches and iPhones. Data collected includes active monitoring of speech, stance, coordination, gait and patient-reported symptoms.	2 years
Primary	Patient-Reported Questionnaires of Health	Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)	2 years
Primary	Falls Questionnaire	Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month	2 years
Primary	Functional Staging	Clinician evaluates severity of ataxia symptoms.	2 years
Primary	Timed 25 Foot Walk	Subjects walk for 25 feet, as quickly and safely as possible, while being timed	2 years