Cognitive ImpairmentNCT03104088
Studying Cognition in SPG4
An observational study of Cognitive Impairment and Hereditary Spastic Paraplegia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Hereditary Spastic Paraplegia
- What is being tested?
- CANTAB and MOCA
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2017to 24 Dec 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Probands will be recruited at the HSP Outpatient Clinic of the Department of Neurology in Tübingen. Eligible participants are age 18 to 70 years of age. Group 1 include p: patients with genetically confirmed SPG4 (group 1) and manifest disease with spastic gait disorder. Group 2 includes age- and sex-matched and healthy controls (spouses, other relatives or further healthy controls) with an educational level comparable to group 1 (group 2).
Who may be able to join
- Patient with SPG4 with known SPAST-Mutation (patient group) or healthy control
- Age 18 to 70 years
- Written, informed consent
Who cannot join
- Lack of ability for a written, informed consent
- Presence of gait disorder or other neurological condition (for healthy controls)
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 Cognition in SPG4 Compared to Healthy Controls
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.
Read the detailed description
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls by using the CANTAB® and MoCA.
- Being tested
- CANTAB, MOCA
- Medical subject headings
- Cognitive Dysfunction, Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANTABDiagnostic test
CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)
MOCADiagnostic test
Montreal cognitive assessment (MOCA) in German
| Study group | Role | What they receive |
|---|---|---|
| SPG4 patients | Not described Receives: Diagnostic Test: CANTAB; Diagnostic Test: MOCA | |
| Healthy controls | Not described Receives: Diagnostic Test: CANTAB; Diagnostic Test: MOCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying cognitive affected domains by using CANTAB
Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB
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 posted7 Apr 2017
- Study start10 May 2017
- Primary completion24 Dec 2017
- Study completion24 Dec 2017
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 Cognitive ImpairmentStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ludger Schöls, University Hospital Tuebingen
- Investigators
- Ludger Schöls, Prof. Dr., Principal investigator, University Hospital Tübingen, Center for Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104088
- Sponsor's protocol ID
- Cognition_SPG4
- Status last verified
- Aug 2020
- First submitted
- 23 Mar 2017
- Last updated
- 28 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 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Cognition in SPG4 Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT03104088
- Acronym / sponsor ID
- Cognition_SPG4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 24 Dec 2017 (actual)
- Study completion
- 24 Dec 2017 (actual)
- First posted
- 7 Apr 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 cognitive levels of patients with SPG4 mutations to healthy controls.
Detailed description
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls by using the CANTAB® and MoCA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPG4 patients | – | Diagnostic Test: CANTAB, Diagnostic Test: MOCA |
| Healthy controls | – | Diagnostic Test: CANTAB, Diagnostic Test: MOCA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Probands will be recruited at the HSP Outpatient Clinic of the Department of Neurology in Tübingen. Eligible participants are age 18 to 70 years of age. Group 1 include p: patients with genetically confirmed SPG4 (group 1) and manifest disease with spastic gait disorder. Group 2 includes age- and sex-matched and healthy controls (spouses, other relatives or further healthy controls) with an educational level comparable to group 1 (group 2).
Key inclusion criteria (3 listed)
- Patient with SPG4 with known SPAST-Mutation (patient group) or healthy control
- Age 18 to 70 years
- Written, informed consent
Key exclusion criteria (2 listed)
- Lack of ability for a written, informed consent
- Presence of gait disorder or other neurological condition (for healthy controls)
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 |
|---|---|---|
| CANTABCANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG) | Diagnostic test | Healthy controls, SPG4 patients |
| MOCAMontreal cognitive assessment (MOCA) in German | Diagnostic test | Healthy controls, SPG4 patients |
Primary outcome
Identifying cognitive affected domains by using CANTAB
Time frame: day 1
Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB
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 28 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.
- Article Link (DOI)Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
Ludger Schöls, Prof. Dr. principal investigator
University Hospital Tübingen, Center for Neurology
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 Cognitive Impairment and Hereditary Spastic Paraplegia, 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 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: finished, as of the sponsor's last update on 28 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?
Identifying cognitive affected domains by using CANTAB (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 NCT03104088, 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 28 Aug 2020.