Spastic ParaplegiaNCT04006418
A Registered Cohort Study on Spastic Paraplegia
An observational study of Spastic Paraplegia, run by Wan-Jin Chen at 1 site in China.
Trial summary
The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spastic Paraplegia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to Dec 2049
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed in hosipital and their's family
Who may be able to join
- Patients with the clinical diagnosis of spastic paraplegia
- Clinical diagnosis of patients with spastic paraplegia
- Unrelated healthy controls
Who cannot join
- Decline to participate.
- There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital Fujian Medical University
Fuzhou
Wan-Jian Chen, MD, PhD, wanjinchen75@fjmu.edu.cn
Wan-Jin Chen
About this study
The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement..
- Conditions
- Spastic Paraplegia
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Spastic Paraplegia Rating Scale (SPRS)
Disease severity will be assessed by application of the Spastic Paraplegia Rating Scale (SPRS), a clinical rating scale measuring disease severity in Hereditary Spastic Paraplegia (Schule et al. Neurology 2006). The SPRS contains 13 items, each ranging from 0 to 4 points. The total score is calculated as the sum of all items, yielding a range for the total score between 0 and 52. Hereby, higher SPRS total scores indicate more severe disease.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jul 2019
- Primary completionDec 2039 (estimated)
- Study completionDec 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spastic ParaplegiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Wan-Jin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006418
- Sponsor's protocol ID
- MRCTA,ECFAH OF FMU[2019]194
- Status last verified
- Jan 2022
- First submitted
- 1 Jul 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang F, Hu J, Xiao Z, Lin C, Huang Z, Wang N, Liu Y. Spinal cord cross sign: a potential marker for hereditary spastic paraplegia type 5. Neuroradiology. 2025 Apr;67(4):1081-1090. doi: 10.1007/s00234-025-03543-y. Epub 2025 Jan 24.
PubMed 39853345Tu Y, Liu Y, Fan S, Weng J, Li M, Zhang F, Fu Y, Hu J. Relationship between brain white matter damage and grey matter atrophy in hereditary spastic paraplegia types 4 and 5. Eur J Neurol. 2024 Aug;31(8):e16310. doi: 10.1111/ene.16310. Epub 2024 Apr 23.
PubMed 38651515Qiu YS, Zeng YH, Yuan RY, Ye ZX, Bi J, Lin XH, Chen YJ, Wang MW, Liu Y, Yao SB, Chen YK, Jiang JY, Lin Y, Lin X, Wang N, Fu Y, Chen WJ. Chinese patients with hereditary spastic paraplegias (HSPs): a protocol for a hospital-based cohort study. BMJ Open. 2022 Jan 11;12(1):e054011. doi: 10.1136/bmjopen-2021-054011.
PubMed 35017251Lin Q, Liu Y, Ye Z, Hu J, Cai W, Weng Q, Chen WJ, Wang N, Cao D, Lin Y, Fu Y. Potential markers for sample size estimations in hereditary spastic paraplegia type 5. Orphanet J Rare Dis. 2021 Sep 19;16(1):391. doi: 10.1186/s13023-021-02014-w.
PubMed 34538260
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Cohort Study on Spastic Paraplegia
- ClinicalTrials.gov ID
- NCT04006418
- Acronym / sponsor ID
- MRCTA,ECFAH OF FMU[2019]194
- Conditions
- Spastic Paraplegia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wan-Jin ChenUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Dec 2039 (estimated)
- Study completion
- Dec 2049 (estimated)
- First posted
- 5 Jul 2019 (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.
The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement..
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed in hosipital and their's family
Key inclusion criteria (3 listed)
- Patients with the clinical diagnosis of spastic paraplegia
- Clinical diagnosis of patients with spastic paraplegia
- Unrelated healthy controls
Key exclusion criteria (2 listed)
- Decline to participate.
- There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
Spastic Paraplegia Rating Scale (SPRS)
Time frame: 6 months
Disease severity will be assessed by application of the Spastic Paraplegia Rating Scale (SPRS), a clinical rating scale measuring disease severity in Hereditary Spastic Paraplegia (Schule et al. Neurology 2006). The SPRS contains 13 items, each ranging from 0 to 4 points. The total score is calculated as the sum of all items, yielding a range for the total score between 0 and 52. Hereby, higher SPRS total scores indicate more severe disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 39853345Zhang F, Hu J, Xiao Z, Lin C, Huang Z, Wang N, Liu Y. Spinal cord cross sign: a potential marker for hereditary spastic paraplegia type 5. Neuroradiology. 2025 Apr;67(4):1081-1090. doi: 10.1007/s00234-025-03543-y. Epub 2025 Jan 24.
- Derived from this study: PubMed 38651515Tu Y, Liu Y, Fan S, Weng J, Li M, Zhang F, Fu Y, Hu J. Relationship between brain white matter damage and grey matter atrophy in hereditary spastic paraplegia types 4 and 5. Eur J Neurol. 2024 Aug;31(8):e16310. doi: 10.1111/ene.16310. Epub 2024 Apr 23.
- Derived from this study: PubMed 35017251Qiu YS, Zeng YH, Yuan RY, Ye ZX, Bi J, Lin XH, Chen YJ, Wang MW, Liu Y, Yao SB, Chen YK, Jiang JY, Lin Y, Lin X, Wang N, Fu Y, Chen WJ. Chinese patients with hereditary spastic paraplegias (HSPs): a protocol for a hospital-based cohort study. BMJ Open. 2022 Jan 11;12(1):e054011. doi: 10.1136/bmjopen-2021-054011.
- Derived from this study: PubMed 34538260Lin Q, Liu Y, Ye Z, Hu J, Cai W, Weng Q, Chen WJ, Wang N, Cao D, Lin Y, Fu Y. Potential markers for sample size estimations in hereditary spastic paraplegia type 5. Orphanet J Rare Dis. 2021 Sep 19;16(1):391. doi: 10.1186/s13023-021-02014-w.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Paraplegia, run by Wan-Jin Chen at 1 site in China.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lin, MD,PhD (+13615039153, wanjinchen75@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spastic Paraplegia Rating Scale (SPRS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006418, which also lists 4 linked publications.
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 19 Jan 2022.