SPG4NCT03204773
Studying Non-motor Symptoms in HSP
An observational study of SPG4, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SPG4
- What is being tested?
- EuroQol five dimensions questionaire (EQ-5D), Modified Fatigue Impact Scale (MFI) and Brief Pain Inventory (BPI)
- How many people
- 236 participants
- Where
- 1 siteGermany
- Study dates
- 28 Apr 2018to 30 Jul 2019
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: We recruit known patients to our department or via patient interest groups.
Who may be able to join
- Group 1: Patients with HSP (hereditary spastic paraplegia)
- Group 2: Healthy controls
- Age 18 to 70 years
- Written, informed consent
Who cannot join
- Lack of ability for a written, informed consent
- Presence of spastic gait disorder or other neurological condition (Group 2)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tübingen, Center for Neurology
Tübingen, 72076
About this study
Official title: Studying Non-motor Symptoms in Patients With Hereditary Spastic Paraplegia (HSP) Compared to Healthy Controls
Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires
Read the detailed description
https://lamapoll.de/NMS_in_HSP
- Conditions
- SPG4
- Being tested
- EuroQol five dimensions questionaire (EQ-5D), Modified Fatigue Impact Scale (MFI), Brief Pain Inventory (BPI), Becks Depression Inventory (BDI), Restless-leg Questionaire (RLS diagnostic criteria)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuroQol five dimensions questionaire (EQ-5D)Diagnostic test
Testing quality of life.
Modified Fatigue Impact Scale (MFI)Diagnostic test
Screening for fatigue
Brief Pain Inventory (BPI)Diagnostic test
Testing for pain
Becks Depression Inventory (BDI)Diagnostic test
Screening for depression
Restless-leg Questionaire (RLS diagnostic criteria)Diagnostic test
Testing for restless-legs
| Study group | Role | What they receive |
|---|---|---|
| HSP patients | Patients with hereditary spastic paraplegia regardless of their genetic mutation Receives: Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D); Diagnostic Test: Modified Fatigue Impact Scale (MFI); Diagnostic Test: Brief Pain Inventory (BPI); Diagnostic Test: Becks Depression Inventory (BDI); Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria) | |
| Healthy controls | healthy controls (spouses, relatives, or other healthy controls) Receives: Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D); Diagnostic Test: Modified Fatigue Impact Scale (MFI); Diagnostic Test: Brief Pain Inventory (BPI); Diagnostic Test: Becks Depression Inventory (BDI); Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of relevant non-motor symptoms in SPG4
By using the five mentioned scales we try to identify relevant non-motor symptoms
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start28 Apr 2018
- Primary completion1 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SPG4Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tim W. Rattay, University Hospital Tuebingen
- Investigators
- Tim W. Rattay, MD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204773
- Sponsor's protocol ID
- NMS in HSP
- Status last verified
- Aug 2020
- First submitted
- 26 Jun 2017
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rattay TW, Boldt A, Volker M, Wiethoff S, Hengel H, Schule R, Schols L. Non-motor symptoms are relevant and possibly treatable in hereditary spastic paraplegia type 4 (SPG4). J Neurol. 2020 Feb;267(2):369-379. doi: 10.1007/s00415-019-09573-w. Epub 2019 Oct 23.
PubMed 31646384
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Non-motor Symptoms in Patients With Hereditary Spastic Paraplegia (HSP) Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT03204773
- Acronym / sponsor ID
- NMS in HSP
- Conditions
- SPG4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 2 Jul 2017 (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.
Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires
Detailed description
https://lamapoll.de/NMS_in_HSP
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSP patients | – | Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D), Diagnostic Test: Modified Fatigue Impact Scale (MFI), Diagnostic Test: Brief Pain Inventory (BPI), Diagnostic Test: Becks Depression Inventory (BDI), Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria)Patients with hereditary spastic paraplegia regardless of their genetic mutation |
| Healthy controls | – | Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D), Diagnostic Test: Modified Fatigue Impact Scale (MFI), Diagnostic Test: Brief Pain Inventory (BPI), Diagnostic Test: Becks Depression Inventory (BDI), Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria)healthy controls (spouses, relatives, or other healthy controls) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We recruit known patients to our department or via patient interest groups.
Key inclusion criteria (4 listed)
- Group 1: Patients with HSP (hereditary spastic paraplegia)
- Group 2: Healthy controls
- Age 18 to 70 years
- Written, informed consent
Key exclusion criteria (2 listed)
- Lack of ability for a written, informed consent
- Presence of spastic gait disorder or other neurological condition (Group 2)
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 |
|---|---|---|
| EuroQol five dimensions questionaire (EQ-5D)Testing quality of life. | Diagnostic test | HSP patients, Healthy controls |
| Modified Fatigue Impact Scale (MFI)Screening for fatigue | Diagnostic test | HSP patients, Healthy controls |
| Brief Pain Inventory (BPI)Testing for pain | Diagnostic test | HSP patients, Healthy controls |
| Becks Depression Inventory (BDI)Screening for depression | Diagnostic test | HSP patients, Healthy controls |
| Restless-leg Questionaire (RLS diagnostic criteria)Testing for restless-legs | Diagnostic test | HSP patients, Healthy controls |
Primary outcome
Identification of relevant non-motor symptoms in SPG4
Time frame: day 1
By using the five mentioned scales we try to identify relevant non-motor symptoms
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 27 Aug 2020.
- Results publication: PubMed 31646384Rattay TW, Boldt A, Volker M, Wiethoff S, Hengel H, Schule R, Schols L. Non-motor symptoms are relevant and possibly treatable in hereditary spastic paraplegia type 4 (SPG4). J Neurol. 2020 Feb;267(2):369-379. doi: 10.1007/s00415-019-09573-w. Epub 2019 Oct 23.
- Link Citation (DOI)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for SPG4
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Spastic Paraplegia - Centers of Excellence Research Network
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Hereditary Spastic Paraplegia Genomic Sequencing Initiative (HSPseq)
Hereditary Spastic Paraplegia, Neurodegenerative Diseases
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Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
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The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4
Hereditary Spastic Paraplegia, Hereditary, Spastic Paraplegia, Autosomal Dominant
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.
Tim W. Rattay, MD principal investigator
Researcher
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 SPG4, run by University Hospital Tuebingen at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 27 Aug 2020. 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 Germany. 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?
Identification of relevant non-motor symptoms in SPG4 (time frame: day 1). 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 NCT03204773, which also lists 1 linked publication.
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 27 Aug 2020.