Spinocerebellar Ataxia Type 1IDEANCT04268147
Instrumented Data Exchange for Ataxia Study
An observational study of Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, run by University of Chicago at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3
- How many people
- 128 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2019to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ataxia clinics
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- dementia that limits subjects' ability to follow directions
- pain that limits mobility
- SCA: enrolled in a clinical drug trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21231
Mass General Hospital
Boston, Massachusetts, 02114
The University of Chicago
Chicago, Illinois, 60637
University of California-Los Angeles
Los Angeles, California, 90095
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: APDM Instrumented Data Exchange for Ataxia (IDEA) Study
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.
- Conditions
- Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Friedreich Ataxia
- Medical subject headings
- Spinocerebellar Ataxias, Machado-Joseph Disease, Friedreich Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinocerebellar Ataxia-1 | individuals with a genetically confirmed diagnosis of SCA-1 | |
| Spinocerebellar Ataxia-2 | individuals with a genetically confirmed diagnosis of SCA-2 | |
| Spinocerebellar Ataxia-3 | individuals with a genetically confirmed diagnosis of SCA-3 | |
| Spinocerebellar Ataxia-6 | individuals with a genetically confirmed diagnosis of SCA-6 | |
| Freidreich's Ataxia | individuals with a genetically confirmed diagnosis of FA | |
| FA Controls | Healthy, age-matched controls | |
| SCA Controls | Healthy, age-matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
iSARA
measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Daily Life (UChicago site ONLY)
APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects
Measured: 2 weeks
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.
Measured: 2 years
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)
Measured: 2 years
Falls Questionnaire
Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month
Measured: 2 years
Functional Staging
Clinician evaluates severity of ataxia symptoms.
Measured: 2 years
Timed 25 Foot Walk
Subjects walk for 25 feet, as quickly and safely as possible, while being timed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Jun 2019
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar Ataxia Type 1Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268147
- Sponsor's protocol ID
- IRB18-1580
- Acronym
- IDEA
- Status last verified
- May 2024
- First submitted
- 4 Feb 2020
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APDM Instrumented Data Exchange for Ataxia (IDEA) Study
- ClinicalTrials.gov ID
- NCT04268147
- Acronym / sponsor ID
- IDEA / IRB18-1580
- Conditions
- Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Friedreich Ataxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Pfizer, Biogen, APDM Wearable Technologies
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Spinocerebellar Ataxia-1 | – | –individuals with a genetically confirmed diagnosis of SCA-1 |
| Spinocerebellar Ataxia-2 | – | –individuals with a genetically confirmed diagnosis of SCA-2 |
| Spinocerebellar Ataxia-3 | – | –individuals with a genetically confirmed diagnosis of SCA-3 |
| Spinocerebellar Ataxia-6 | – | –individuals with a genetically confirmed diagnosis of SCA-6 |
| Freidreich's Ataxia | – | –individuals with a genetically confirmed diagnosis of FA |
| FA Controls | – | –Healthy, age-matched controls |
| SCA Controls | – | –Healthy, age-matched controls |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ataxia clinics
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- dementia that limits subjects' ability to follow directions
- pain that limits mobility
- SCA: enrolled in a clinical drug trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
iSARA
Time frame: 2 years
measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)
SARA
Time frame: 2 years
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
mFARS
Time frame: 2 years
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
Daily Life (UChicago site ONLY)
Time frame: 2 weeks
APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects
Ataxia App on Watch/iPhone
Time frame: 2 years
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.
Patient-Reported Questionnaires of Health
Time frame: 2 years
Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)
Falls Questionnaire
Time frame: 2 years
Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month
Functional Staging
Time frame: 2 years
Clinician evaluates severity of ataxia symptoms.
Timed 25 Foot Walk
Time frame: 2 years
Subjects walk for 25 feet, as quickly and safely as possible, while being timed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, run by University of Chicago at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iSARA (time frame: 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.