Neuropsychiatry and Cognition in SCA3/MJD (NCT04714307) | Clinical Trial Compass
UnknownNot Applicable
Neuropsychiatry and Cognition in SCA3/MJD
Brazil144 participantsStarted 2019-12-13
Plain-language summary
This research investigates how cognitive-affective aspects evolve during the course of SCA3/MJD. Due to COVID-19 pandemics, this study protocol was adapted for online-only consultations. Evaluations happening after March 2020 have been done by videocall with patients, and no neurological evaluation was thus performed on these patients. A scale on Activities of Daily Living was added to the online protocol to replace SARA, SCAFI and CCFS scales.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic:
* older than 18 year old;
* molecular diagnosis of SCA3/MJD;
* SARA\>2.5.
* At 50% risk:
* older than 18 year old;
* have a parent with molecular diagnosis of SCA3/MJD;
* SARA\<3.
* Healthy Controls
* older than 18 year old;
* no genetic relationship with a SCA3/MJD carrier.
Exclusion Criteria:
* Non agreement in signing the informed consent;
* Healthy Controls: having any history of genetic disorders in their families or any psychiatric or neurologic disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cerebellar Cognitive Affective Syndrome Scale
Timeframe: Through study completion, an average of 1 year
2
Trail-Making Test Part A and B
Timeframe: Through study completion, an average of 1 year
3
Stroop Color-Word Test
Timeframe: Through study completion, an average of 1 year
4
Emotion Attribution impairment in SCA3/MJD
Timeframe: Through study completion, an average of 1 year
5
Emotion Attribution in different phases of the disease
Timeframe: Through study completion, an average of 1 year
6
Hamilton Anxiety Rating Scale
Timeframe: Through study completion, an average of 1 year
7
Hamilton Depression Rating Scale
Timeframe: Through study completion, an average of 1 year