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RecruitingNCT03336008HK_SCA_RegUpdated Aug 27, 2024

Hong Kong Spinocerebellar Ataxias Registry

An observational study in Spinocerebellar Ataxia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Spinocerebellar ataxias (SCA) 1, 2, 3 and 6 are the most common, autosomal dominantly inherited cerebellar degenerations. And in the Chinese population, the most common SCA is SCA3 and the frequency of SCA 3 among SCA patients is 72.5%, followed by SCA 2 that the frequency is 12% among SCA patients. For SCA 1, the frequency among SCA patients is 7%. Even SCAs are rare diseases, a significant amount of Chinese in Hong Kong still suffer from this disorders. SCA Association in Hong Kong has 88 members who are suffering from spinocerebellar degeneration, many of them have a genetic confirmation. As there are few treatments for SCAs; therefore, understanding SCAs clinical manifestation and disease mechanisms are the first step towards development of effective treatment. The objective of this study is to develop the first SCA registry in Hong Kong with bio-repository bank for clinical and genetic information as well as serum and fibroblasts.

Read the detailed description

All the members from Hong Kong SCA association will be invited and discuss the study with them. After obtaining the informed consent, their genotypes will be determined and collect clinical information. Some of the participant will have clear genotyping via Department of Health. Participants with a genetic confirmation of SCA1, 2, 3, 6, 7, 8 and 12 genes will be included in the study. The relatives of genetically confirmed participants, who also had ataxic symptoms, might be included in the study without further determination of the genotypes.

Detailed clinical history including age of onset, clinical symptoms will be collected. A detailed neurological examination with an emphasis of eye movements (such as pursuit, saccadic, and convergence eye movements). We will also perform SARA scale, a validated ataxia scale. Timed 25 foot-walk test will be performed.

Two-year annual follow-up will be arranged for recruited subject for neurological physical examination, SARA scale, in order to continue assessment for any progress change in disease stage.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

SCA association members or SCA subjects who follow-up in our clinic or refer from other clinic

Inclusion criteria

  1. Age 18 years and above
  2. Presence of symptoms and signs of ataxia
  3. Definite molecular diagnosis of SCA1, 2, 3, 6, 7, 8 or 12 either in the participant or another affected family member
  4. Willingness to participate in the study and ability to give informed consent

Exclusion criteria

Exclusion Criteria:

  1. Known recessive. X-linked, and mitochondrial ataxias
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • Otherno intervention

    No intervention but clinical assessement for all recruited subjects

05

What researchers measure

Primary outcomes

  1. Scale for the assessment and rating of ataxia (SARA) score

    Scale for the assessment and rating of ataxia (total score 0-40)

    Time frame: change from baseline to 2-year follow up

Secondary outcomes

  1. EQ5D Health questionnaire

    EQ-5D is a standardized instrument for measuring generic health status. The health status measured with EQ-5D is used for estimating preference weight for that health status (1-3 in each health status , 0-100 in general today's health status)

    Time frame: change from baseline to 2-year follow up

  2. Patient Health Questionnaire-9 (PHQ-9)

    Depression scale (0-4 in each items)

    Time frame: change from baseline to 2-year follow up

06

Study locations

1 of 1 sites recruiting
  • Prince of Wales Hospital
    Hong Kong, Shatin 000, Hong Kong
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03336008
Lead sponsor
Chinese University of Hong Kong
Responsible party
Dr. Anne YY CHAN (Associate Consultant, Chinese University of Hong Kong) — Principal investigator
First posted
Nov 8, 2017
Start date
Dec 7, 2012
Primary completion
Dec 31, 2034 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
Aug 27, 2024

Study contacts

Anne YY CHAN
Contact
yychananne@gmail.com
(852) 3505 1855
Yixun HAN
Contact
elyiahan@cuhk.edu.hk
(852) 2697 5027
Anne YY CHAN
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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