ParkinsonSensoMo-PDNCT05713721
Sensorimotor Integration in Monogenic Parkinson-dystonia Syndromes
An observational study of Parkinson and Dystonia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Hereditary Parkinson and dystonia syndromes are rare, as are people who carry the predisposition for Parkinson or dystonia but do not have symptoms. It is particularly important to study these people because they are a good model for understanding the development of common non-hereditary Parkinson's and dystonia. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- What is being tested?
- Transcranial magnetic stimulation (TMS), Video-based clinical examination and 24 hours drug withdrawal of dopaminergic medication
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will include symptomatic and asymptomatic carriers of pathogenic variants in the Parkin, PINK1, GCH1, or TAF1 gene, and sex- and age-matched healthy controls.
Who may be able to join
- Pathogenic Parkin, PINK1, GCH1, or TAF1 gene variant
- Age >18 years
- Informed consent
- No movement disorder
- Age >18 years
- Informed consent
- No medication with influences on the central nervous system
Who cannot join
- Age <18 years
- Pregnancy
- Epilepsy
- Medication that reduces the seizure threshold
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institute of Systems Motor Science Lübeck
Lübeck, Schleswig-Holstein, 23562
Anne Weissbach, MD, +49 451 3101 8219, anne.weissbach@neuro.uni-luebeck.de
About this study
Official title: SensoMo-PD: Sensorimotor Integration in Monogenic Parkinson-dystonia Syndromes
Hereditary Parkinson and dystonia syndromes are rare, as are people who carry the predisposition for Parkinson or dystonia but do not have symptoms. It is particularly important to study these people because they are a good model for understanding the development of common non-hereditary Parkinson's and dystonia. To do this, the investigators want to look at how the brain works and how different areas of the brain communicate with each other. The investigators want to identify differences in brain regions connecting perception and action between mutation carriers that develop clinical symptoms and those who stay healthy in different subgroups of inherited Parkinson-dystonia syndromes. Mutation carriers with and without symptoms of three different inherited Parkinson-dystonia syndromes will be investigated at their homes with the help of a mobile examination unit. To detect even subtle signs, which the mutation carriers might not even be aware of, the investigators will use a detailed video-based and -documented movement examination and a non-invasive magnetic stimulation technique that investigates how a sensory, i.e., electrical stimulus can influence the motor response in a hand muscle. Our study will allow the investigators, on the one hand, to define specific markers that protect some mutation carriers from having clinical symptoms and, on the other hand, to identify neurophysiological characteristics that all mutation carriers share whether or not they have clinical symptoms. These are important information for a better understanding of the basis of these disorders and for the development of new treatment strategies, which can also be transferred to genetically-undefined Parkinson's and dystonia syndromes. Through this study, large groups of mutation carriers that have received an in-depth clinical and neurophysiological examination and can be investigated longitudinally in future studies will be build up.
Read the detailed description
Monogenic Parkinson-dystonia syndromes are rare but very valuable model disorders for genetically undefined syndromes, as their genetic cause, i.e., pathogenic gene variants, have been identified. For certain subtypes, even the neuroanatomical basis was discovered. Despite the different genetic and anatomical characteristics, a strong clinical overlap was reported between PARK-Parkin/PARK-PINK1, DYT/PARK-GCH1, and DYT/PARK-TAF1.
Interestingly, previous research in these different Parkinson-dystonia syndromes suggests a distinct pattern of neurophysiological alterations within the primary motor and premotor-motor network for each syndrome. Even asymptomatic, heterozygous mutation carriers, show abnormalities within neurophysiological and in addition, functional, metabolic, and structural imaging studies.
In general, a better clinical and neurophysiological evaluation of asymptomatic compared to symptomatic mutation carriers and healthy controls across subgroups is warranted. However, the number of mutation carriers per subgroup is limited and some are unable to travel to Lübeck to participate in research. To increase the participant size, in addition to the examination in our neurophysiological laboratory, the investigators want to visit and investigate some mutation carriers in their home environment with a mobile examination unit. In this regard, the transcranial magnetic stimulation paradigm of short-latency afferent inhibition (SAI) is of great interest as it can reliably capture the effects of sensory input (median nerve stimulation) on motor output (MEP amplitude) without complex neuronavigation. Additionally, a video-based clinical examination will be performed, which will be rated offline in a blinded fashion by movement disorder specialists to correlate SAI with symptom severity.
Therefore, the proposed project will, for the first time, allow a direct comparison of sensorimotor integration deficits in correlation to clinical signs between three different monogenic Parkinson-dystonia syndromes. Furthermore, contrasting the findings between asymptomatic and symptomatic mutation carriers will help, on the one hand, to draw conclusions on potential protective markers, and on the other hand, to identify neurophysiological endophenotypes. Furthermore, successful completion of the project will generate clinically well-defined monogenic subgroups with particular sensorimotor abnormalities, who can serve as model disorders in further research projects that aim to characterize sensorimotor deficit in a cognitive framework and in a longitudinal fashion.
- Conditions
- Parkinson, Dystonia, DYT3, DYT5, PINK1 Gene Deletion, Dystonia, Familial
- Being tested
- Transcranial magnetic stimulation (TMS), Video-based clinical examination, 24 hours drug withdrawal of dopaminergic medication, Evaluation of deep brain stimulation
- Keywords
- Dystonia, Parkinson's, Parkinson-dystonia, GCH1, Parkin, PINK1, TAF1, XDP, X-linked Dystonia-Parkinsonism
- Medical subject headings
- Dystonia, Dystonic Disorders, Parkinson Disease, Dystonia 3, Torsion, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Device
TMS over the left primary motor cortex will be performed. To investigate sensorimotor integration, an electrical stimulus on the right index finger will precede the TMS pulse.
Video-based clinical examinationOther
A standardized neurological examination will be performed and video taped. The videos will be rated by movement disorder specialists, wo are blinded for the symptom and mutation status of the participants.
24 hours drug withdrawal of dopaminergic medicationOther
Examinations will be done under chronic dopaminergic treatment and after a 24 hours dopaminergic drug withdrawal.
Evaluation of deep brain stimulationOther
Examinations will be done before and after implantation of deep brain stimulation (clinically optimal stimulation vs. switched off stimulation)
| Study group | Role | What they receive |
|---|---|---|
| SMC DYT/PARK-TAF1 | Symptomatic mutation carriers (SMC) of the TAF1 gene, which is associated with X-linked Dystonia-Parkinsonism, will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination; Other: 24 hours drug withdrawal of dopaminergic medication; Other: Evaluation of deep brain stimulation | |
| AMC DYT/PARK-TAF1 | Asymptomatic mutation carriers (AMC) of the TAF1 gene will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination | |
| SMC DYT/PARK-GCH1 | Symptomatic mutation carriers (SMC) of the GCH1 gene, which is associated with dopa-responsive Dystonia, will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination; Other: 24 hours drug withdrawal of dopaminergic medication | |
| AMC DYT/PARK-GCH1 | Asymptomatic mutation carriers (AMC) of the GCH1 gene will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination | |
| SMC PARK-Parkin/PARK-PINK1 | Symptomatic mutation carriers (SMC) of the Parkin or PINK1 genes, which is associated with Parkinsonism, will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination; Other: 24 hours drug withdrawal of dopaminergic medication | |
| AMC PARK-Parkin/PARK-PINK1 | Asymptomatic mutation carriers (SMC) of the Parkin or PINK1 genes will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination | |
| Control group | A healthy control group will be examined. Receives: Device: Transcranial magnetic stimulation (TMS); Other: Video-based clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensorimotor integration in patients with three different monogenic Parkinson-dystonia syndromes.
Transcranial magnetic stimulation (short-latency afferent inhibition)
Measured: Two timepoints (if applicable): With chronic dopaminergic medication vs. 24h drug withdrawal OR before and after deep brain stimulation implantation
Define whether asymptomatic mutation carriers show abnormalities in sensorimotor integration and clinical signs of Parkinson and dystonia upon video examination.
Video based clinical examination
Measured: One timepoint
Correlate clinical symptom severity with changes in sensorimotor integration.
Transcranial magnetic stimulation (short-latency afferent inhibition) and Video based clinical examination
Measured: Two timepoints (patients) or one timepoint (asymptomatic mutation carriers and healthy control participants)
Evaluate treatment effects on sensorimotor integration, e.g., for PARK-Parkin/PARK-PINK1 and DYT/PARK-GCH1 chronic dopaminergic medication and for DYT/PARK-TAF1 deep brain stimulation effects.
Transcranial magnetic stimulation (short-latency afferent inhibition)
Measured: Two timepoints (if applicable): With chronic dopaminergic medication vs. 24h drug withdrawal OR before and after deep brain stimulation implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Anne Weißbach, University Hospital Schleswig-Holstein
- Investigators
- Anne Weissbach, MD, Principal investigator, Institute of Systems Motor Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713721
- Sponsor's protocol ID
- MJFF-022062
- Acronym
- SensoMo-PD
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SensoMo-PD: Sensorimotor Integration in Monogenic Parkinson-dystonia Syndromes
- ClinicalTrials.gov ID
- NCT05713721
- Acronym / sponsor ID
- SensoMo-PD / MJFF-022062
- Conditions
- Parkinson, Dystonia, DYT3, DYT5, PINK1 Gene Deletion, Dystonia, Familial
- Keywords
- Dystonia, Parkinson's, Parkinson-dystonia, GCH1, Parkin, PINK1, TAF1, XDP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2023 (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.
Hereditary Parkinson and dystonia syndromes are rare, as are people who carry the predisposition for Parkinson or dystonia but do not have symptoms. It is particularly important to study these people because they are a good model for understanding the development of common non-hereditary Parkinson's and dystonia. To do this, the investigators want to look at how the brain works and how different areas of the brain communicate with each other. The investigators want to identify differences in brain regions connecting perception and action between mutation carriers that develop clinical symptoms and those who stay healthy in different subgroups of inherited Parkinson-dystonia syndromes. Mutation carriers with and without symptoms of three different inherited Parkinson-dystonia syndromes will be investigated at their homes with the help of a mobile examination unit. To detect even subtle signs, which the mutation carriers might not even be aware of, the investigators will use a detailed video-based and -documented movement examination and a non-invasive magnetic stimulation technique that investigates how a sensory, i.e., electrical stimulus can influence the motor response in a hand muscle. Our study will allow the investigators, on the one hand, to define specific markers that protect some mutation carriers from having clinical symptoms and, on the other hand, to identify neurophysiological characteristics that all mutation carriers share whether or not they have clinical symptoms. These are important information for a better understanding of the basis of these disorders and for the development of new treatment strategies, which can also be transferred to genetically-undefined Parkinson's and dystonia syndromes. Through this study, large groups of mutation carriers that have received an in-depth clinical and neurophysiological examination and can be investigated longitudinally in future studies will be build up.
Detailed description
Monogenic Parkinson-dystonia syndromes are rare but very valuable model disorders for genetically undefined syndromes, as their genetic cause, i.e., pathogenic gene variants, have been identified. For certain subtypes, even the neuroanatomical basis was discovered. Despite the different genetic and anatomical characteristics, a strong clinical overlap was reported between PARK-Parkin/PARK-PINK1, DYT/PARK-GCH1, and DYT/PARK-TAF1.
Interestingly, previous research in these different Parkinson-dystonia syndromes suggests a distinct pattern of neurophysiological alterations within the primary motor and premotor-motor network for each syndrome. Even asymptomatic, heterozygous mutation carriers, show abnormalities within neurophysiological and in addition, functional, metabolic, and structural imaging studies.
In general, a better clinical and neurophysiological evaluation of asymptomatic compared to symptomatic mutation carriers and healthy controls across subgroups is warranted. However, the number of mutation carriers per subgroup is limited and some are unable to travel to Lübeck to participate in research. To increase the participant size, in addition to the examination in our neurophysiological laboratory, the investigators want to visit and investigate some mutation carriers in their home environment with a mobile examination unit. In this regard, the transcranial magnetic stimulation paradigm of short-latency afferent inhibition (SAI) is of great interest as it can reliably capture the effects of sensory input (median nerve stimulation) on motor output (MEP amplitude) without complex neuronavigation. Additionally, a video-based clinical examination will be performed, which will be rated offline in a blinded fashion by movement disorder specialists to correlate SAI with symptom severity.
Therefore, the proposed project will, for the first time, allow a direct comparison of sensorimotor integration deficits in correlation to clinical signs between three different monogenic Parkinson-dystonia syndromes. Furthermore, contrasting the findings between asymptomatic and symptomatic mutation carriers will help, on the one hand, to draw conclusions on potential protective markers, and on the other hand, to identify neurophysiological endophenotypes. Furthermore, successful completion of the project will generate clinically well-defined monogenic subgroups with particular sensorimotor abnormalities, who can serve as model disorders in further research projects that aim to characterize sensorimotor deficit in a cognitive framework and in a longitudinal fashion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SMC DYT/PARK-TAF1 | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examination, Other: 24 hours drug withdrawal of dopaminergic medication, Other: Evaluation of deep brain stimulationSymptomatic mutation carriers (SMC) of the TAF1 gene, which is associated with X-linked Dystonia-Parkinsonism, will be examined. |
| AMC DYT/PARK-TAF1 | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examinationAsymptomatic mutation carriers (AMC) of the TAF1 gene will be examined. |
| SMC DYT/PARK-GCH1 | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examination, Other: 24 hours drug withdrawal of dopaminergic medicationSymptomatic mutation carriers (SMC) of the GCH1 gene, which is associated with dopa-responsive Dystonia, will be examined. |
| AMC DYT/PARK-GCH1 | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examinationAsymptomatic mutation carriers (AMC) of the GCH1 gene will be examined. |
| SMC PARK-Parkin/PARK-PINK1 | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examination, Other: 24 hours drug withdrawal of dopaminergic medicationSymptomatic mutation carriers (SMC) of the Parkin or PINK1 genes, which is associated with Parkinsonism, will be examined. |
| AMC PARK-Parkin/PARK-PINK1 | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examinationAsymptomatic mutation carriers (SMC) of the Parkin or PINK1 genes will be examined. |
| Control group | – | Device: Transcranial magnetic stimulation (TMS), Other: Video-based clinical examinationA healthy control group will be examined. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will include symptomatic and asymptomatic carriers of pathogenic variants in the Parkin, PINK1, GCH1, or TAF1 gene, and sex- and age-matched healthy controls.
Key inclusion criteria (7 listed)
- Pathogenic Parkin, PINK1, GCH1, or TAF1 gene variant
- Age >18 years
- Informed consent
- No movement disorder
- Age >18 years
Key exclusion criteria (4 listed)
- Age <18 years
- Pregnancy
- Epilepsy
- Medication that reduces the seizure threshold
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 |
|---|---|---|
| Transcranial magnetic stimulation (TMS)TMS over the left primary motor cortex will be performed. To investigate sensorimotor integration, an electrical stimulus on the right index finger will precede the TMS pulse. | Device | AMC DYT/PARK-GCH1, AMC DYT/PARK-TAF1, AMC PARK-Parkin/PARK-PINK1, Control group, SMC DYT/PARK-GCH1, SMC DYT/PARK-TAF1, SMC PARK-Parkin/PARK-PINK1 |
| Video-based clinical examinationA standardized neurological examination will be performed and video taped. The videos will be rated by movement disorder specialists, wo are blinded for the symptom and mutation status of the participants. | Other | AMC DYT/PARK-GCH1, AMC DYT/PARK-TAF1, AMC PARK-Parkin/PARK-PINK1, Control group, SMC DYT/PARK-GCH1, SMC DYT/PARK-TAF1, SMC PARK-Parkin/PARK-PINK1 |
| 24 hours drug withdrawal of dopaminergic medicationExaminations will be done under chronic dopaminergic treatment and after a 24 hours dopaminergic drug withdrawal. | Other | SMC DYT/PARK-GCH1, SMC DYT/PARK-TAF1, SMC PARK-Parkin/PARK-PINK1 |
| Evaluation of deep brain stimulationExaminations will be done before and after implantation of deep brain stimulation (clinically optimal stimulation vs. switched off stimulation) | Other | SMC DYT/PARK-TAF1 |
Primary outcome
Contrast sensorimotor integration in patients with three different monogenic Parkinson-dystonia syndromes.
Time frame: Two timepoints (if applicable): With chronic dopaminergic medication vs. 24h drug withdrawal OR before and after deep brain stimulation implantation
Transcranial magnetic stimulation (short-latency afferent inhibition)
Define whether asymptomatic mutation carriers show abnormalities in sensorimotor integration and clinical signs of Parkinson and dystonia upon video examination.
Time frame: One timepoint
Video based clinical examination
Correlate clinical symptom severity with changes in sensorimotor integration.
Time frame: Two timepoints (patients) or one timepoint (asymptomatic mutation carriers and healthy control participants)
Transcranial magnetic stimulation (short-latency afferent inhibition) and Video based clinical examination
Evaluate treatment effects on sensorimotor integration, e.g., for PARK-Parkin/PARK-PINK1 and DYT/PARK-GCH1 chronic dopaminergic medication and for DYT/PARK-TAF1 deep brain stimulation effects.
Time frame: Two timepoints (if applicable): With chronic dopaminergic medication vs. 24h drug withdrawal OR before and after deep brain stimulation implantation
Transcranial magnetic stimulation (short-latency afferent inhibition)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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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.
Anne Weissbach, MD principal investigator
Institute of Systems Motor Science
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 Parkinson and Dystonia, run by University Hospital Schleswig-Holstein 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Weissbach, MD (+49 451 3101 8219, anne.weissbach@neuro.uni-luebeck.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast sensorimotor integration in patients with three different monogenic Parkinson-dystonia syndromes. (time frame: Two timepoints (if applicable): With chronic dopaminergic medication vs. 24h drug withdrawal OR before and after deep brain stimulation implantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2023.