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| Name | Class |
|---|---|
| Dr. Glenn T. Stebbins (Rush University Medical Center ) | UNKNOWN |
| The University of Texas Health Science Center, Houston | OTHER |
| Nancy LaPelle | UNKNOWN |
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The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Manifest HDGEC Participant |
| ||
| Early-Manifest HDGEC Participant |
| ||
| Corresponding HDGEC participant Companion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FuRST 2.0 | Behavioral | Cognitive Pre-testing of new Functional Rating Scale |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis | The primary assessment will use qualitative analysis of the cognitive interview to determine the usability of the FuRST 2.0 scale in the HD population. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale | The secondary outcome measure will be evaluated using the Kolmogorov-Smirnov test | 8 months |
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Main criteria for inclusion:
Pre-Manifest HDGECs
Criteria 1-4, and:
CAG length greater than or equal to 40
Disease Burden Score greater than or equal to 250 (calculated by the equation:
[CAGn-35.5] X age)
UHDRS Diagnostic Confidence Level (DCL) < 3
At least five Pre-Manifest HDGEC participants should have a companion who is willing to participate in this study and complete the scale independently.
Early-Manifest (Stage 1&2) HDGECs
Criteria 1-4, and:
Main criteria for exclusion:
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Participants: Individuals of either gender, equal to or greater than 18 years of age. HDGEC Pre-Manifest and Early-Manifest participants (see inclusion criteria) will be recruited from English speaking Enroll-HD sites.
Companions: Available companions for HDGEC Pre-Manifest participants will be encouraged to participate (at least five Pre-Manifest's companions are required). Companions will be identified for HDGEC Early-Manifest participants and asked to participate. Companion's participation for HDGEC Early-Manifest participant is mandatory as specified in the inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Movement Disorders Center, P.C. | Englewood | Colorado | 80113 | United States | ||
| Hereditary Neurology Disease Centre, Inc. |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Wichita |
| Kansas |
| 67226 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting) | Toronto | Ontario | M3B 2S7 | Canada |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |