DystoniaGenoDYTNCT06999096
Long-read Genome Sequencing for the Molecular Diagnosis of Dystonia
A study testing Long-read whole genome sequencing in people with Dystonia and Movement Disorders, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Dystonia is a motor disorder caused by involuntary, intermittent, or sustained muscle contractions, leading to abnormal movements or postures. It can affect any body region and often results in significant functional disability and healthcare burden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dystonia, Movement Disorders, Combined Dystonia
- What is being tested?
- Long-read whole genome sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Apr 2026to Aug 2030
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Index case affected by familial dystonia (≥1 first-degree relative affected) and/or sporadic early-onset dystonia (symptom onset before age 50), meeting the criteria of the PFMG-2025 program.
- Index case who has undergone short-read genome sequencing, which did not lead to a molecular diagnosis.
- Ability to understand and sign informed consent by the index case and/or their parents or legal guardians for patients under 18 years of age.
- Availability of a blood sample from the index case and at least two relatives, either affected or unaffected.
- Symptomatic or asymptomatic relative of an index case, who has also undergone short-read genome sequencing without a conclusive molecular diagnosis.
- Ability to understand and sign informed consent.
Who cannot join
- Index case or relatives who are not affiliated with or not beneficiaries of a social security scheme.
- Index case and their parents presenting with a condition that, in the opinion of the investigator, would contraindicate participation in the study.
- Suspected non-genetic etiology (e.g., perinatal hypoxic-ischemic injury, kernicterus, history of severe head trauma or central nervous system infection).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
Agathe ROUBERTIE, Professor, +33 467336733 ext. +33, a-roubertie@chu-montpellier.fr
- Recruiting
CHRU Nancy
Nancy, 54000
Solène FRISMAND, Doctor, +33 383852603 ext. +33, s.frismand@chru-nancy.fr
- Not yet recruiting
Hôpital Pitié Salpêtrière- APHP
Paris, 75013
Emmanuel FLAMAND-ROZE, Professor, +33 142162748 ext. +33, emmanuel.flamand-roze@aphp.fr
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Thomas WIRTH, Doctor, +33 388128019 ext. +33, thomas.wirth@chru-strasbourg.fr
About this study
Official title: Evaluation of the Value of Long-read Genome Sequencing for the Molecular Diagnosis of Dystonia: a Prospective Multicenter Study
Dystonia is a motor disorder caused by involuntary, intermittent, or sustained muscle contractions, leading to abnormal movements or postures. It can affect any body region and often results in significant functional disability and healthcare burden. Although its familial nature was recognized early on, the advent of high-throughput DNA sequencing has dramatically increased the identification of dystonia-associated genes. Dystonia now encompasses all modes of inheritance-autosomal dominant (e.g., TOR1A, KMT2B), autosomal recessive, X-linked, and mitochondrial-and over 100 genes have been implicated. Many forms involve structural variants (SVs) or copy number variations (CNVs), which are challenging to detect using standard short-read sequencing (srWGS).
Molecular diagnosis is essential, ending the diagnostic odyssey and enabling genetic counseling, prognosis, reproductive planning, and-in some cases-targeted therapies. For instance, GNAO1-related dystonia may respond to deep brain stimulation, while dopa-responsive dystonia benefits from levodopa.
Read more
Despite advances, srWGS has key limitations, especially for detecting repeat expansions, SVs, and phasing alleles. This likely explains the low diagnostic yield in dystonia compared to other neurological disorders, with over 70% of cases remaining unsolved.
Long-read sequencing (lrWGS), such as Oxford Nanopore technology, overcomes many of these challenges by reading native DNA fragments thousands of bases long. It enables comprehensive detection of SNVs, indels, SVs, CNVs, methylation changes, and repeat expansions-including known and newly discovered pathogenic expansions (e.g., in NOTCH2NLC). It also allows phasing without parental samples, which is crucial in recessive cases.
The investigators propose that lrWGS could significantly increase the diagnostic yield in dystonia, improving patient care, enabling appropriate genetic counseling, and paving the way for personalized treatment strategies.
Read the detailed description
Dystonia is a motor disorder characterized by abnormal movements and/or postures. It is caused by involuntary, intermittent, or sustained muscle contractions. Dystonia can affect all body segments, leading to highly variable and often severe functional impairment with a significant burden on healthcare systems.
The familial nature of some generalized dystonias was recognized as early as the 1940s. With the development and increased availability of high-throughput DNA sequencing technologies since the early 2010s, there has been an exponential rise in the discovery of genes associated with neurological phenotypes in which dystonia is either the main manifestation or part of a broader clinical picture. Dystonia is now known to be associated with all modes of inheritance, including autosomal dominant forms (e.g., TOR1A, KMT2B), autosomal recessive forms often presenting with complex phenotypes, X-linked dominant (e.g., WDR45) and recessive (e.g., TAF1) forms, and even mitochondrial inheritance.
To date, over 100 genes have been linked to dystonic phenotypes, highlighting the significant genetic heterogeneity of this condition. Many genetically determined dystonic syndromes are associated with structural variants (SVs) or copy number variations (CNVs), which are difficult to detect using routine short-read sequencing technologies.
Molecular diagnosis is crucial in the management of dystonia. It provides a definitive and precise diagnosis, bringing an end to the diagnostic odyssey for patients and their families. It also enables accurate genetic counseling, offering information on inheritance risks and the potential for other family members to be affected. In some cases, a molecular diagnosis directly influences therapeutic decisions. For example, pathogenic variants in GNAO1 are associated with early-onset dystonic syndromes that respond well to deep brain stimulation of the globus pallidus. Specific symptomatic treatments have been proposed for certain dystonias, such as levodopa in dopa-responsive dystonia. At the population level, identifying new genes or molecular causes can reveal novel pathogenic mechanisms and facilitate the development of animal or cellular models, paving the way for future gene therapies.
Over the past decade, the growing availability of short-read DNA sequencing technologies has enabled the simultaneous analysis of numerous dystonia-associated genes. In routine diagnostics, short-read sequencing involves fragmenting DNA into small pieces (usually a few hundred base pairs), which are then sequenced from both ends.
This approach has limitations, particularly for detecting repeat expansions that exceed the size of the sequenced fragments. These limitations may partly explain why a relatively small proportion of dystonia cases receive a molecular diagnosis compared to other neurological disorders like cerebellar ataxias or hereditary spastic paraplegias. Overall, more than 70% of dystonia patients sequenced via short-read WGS remain without a molecular diagnosis, despite strong clinical indicators of a genetic etiology.
To overcome these limitations, long-read DNA sequencing technologies have been developed. Unlike short-read methods, long-read sequencing preserves native DNA fragment sizes, which can span thousands of bases. One such approach (Oxford Nanopore) sequences DNA based on ionic current changes as the molecule passes through a nanometer-scale pore. Long-read sequencing offers several advantages. Like short-read methods, it detects small variants (SNVs and indels). However, it also excels at identifying structural variants, CNVs, methylation changes, and especially repeat expansions-key elements often missed by standard methods.
In neurogenetics, long-read sequencing has enabled the accurate detection and quantification of known repeat disorders (e.g., C9orf72 hexanucleotide expansions, RFC1), as well as the discovery of new disease-causing repeat expansions (e.g., GGC repeats in NOTCH2NLC).
It also allows phasing of alleles (cis or trans configurations) without requiring family segregation studies, which is particularly useful in recessive conditions.
Given the current diagnostic limitations of short-read sequencing, the emergence of newly identified repeat expansions, and the demonstrated advantages of long-read sequencing, the investigators hypothesize that a significant proportion of patients with undiagnosed dystonia could benefit from whole-genome long-read sequencing (lrWGS).
Such an approach could, in a single test, overcome many of the key diagnostic blind spots of short-read methods, particularly for detecting repeat expansions and structural variants. This would not only end the diagnostic odyssey for many patients, but also enable appropriate genetic counseling, access to reproductive options such as prenatal or preimplantation diagnosis, and even influence treatment strategies.
- Conditions
- Dystonia, Movement Disorders, Combined Dystonia, Complex Dystonia
- Being tested
- Long-read whole genome sequencing
- Keywords
- Dystonia, Genome Sequencing, Long-read Sequencing, Molecular diagnosis, Neurogenetics
- Medical subject headings
- Dystonia, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-read whole genome sequencingDiagnostic test
Pseudonymized blood samples will undergo high-molecular-weight DNA extraction, followed by long-read whole-genome sequencing (lrWGS) using Oxford Nanopore technology. Index cases will be sequenced at high depth (>30X), while relatives will be multiplexed (>15X). Sequencing data will be analyzed through a dedicated bioinformatics pipeline to detect SNVs, indels, structural variants, and repeat expansions. Results will be interpreted by expert teams and discussed in monthly clinical-genetic meetings. Variants of interest will be validated by appropriate molecular techniques, and family segregation will be assessed when relevant.
| Study group | Role | What they receive |
|---|---|---|
| Dystonia patients without molecular diagnosis | Experimental | Long-read genome sequencing for identification of genetic causes in dystonia patients without molecular diagnosis Receives: Diagnostic Test: Long-read whole genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-read genome sequencing diagnostic rate
Proportion (expressed as a percentage) of families in which a causal genetic variant (classified as class 4 or 5 according to the American College of Medical Genetics and Genomics) explaining the patients' symptoms was identified through long-read genome sequencing, after no diagnosis had been reached using prior short-read genome analysis.
Measured: 18 months
Secondary outcomes (5)
Technical issues rate
Proportion (expressed as a percentage) of families for whom technical difficulties were encountered during long-read genome sequencing and analysis, the proportion for whom solutions were identified, and the proportion for whom it was not possible to obtain a result
Measured: 18 months
Proportion of activable disorders
Proportion (percentage) of families for whom the molecular diagnosis led to a change in clinical management, including therapeutic modification; genetic counseling, prenatal or preimplantation diagnosis for the index case or relatives; detection of a disease-specific complication in the index case or relatives.
Measured: 24 months
New molecular causes of dystonia
Proportion (percentage) of families whose molecular diagnosis revealed a previously unreported genetic cause of dystonia.
Measured: 18 months
Resolution following reanalysis of short-read whole genome sequencing data
Proportion (percentage) of families in which a causal genetic variant was identified using dedicated bioinformatic tools during retrospective reanalysis of the short-read genome.
Measured: 18 months
Medico-economic impact of molecular diagnosis
Assessment of the cost of illness by detailing cost components per patient from a collective perspective, and evaluating the cost invested per additional diagnosis enabled by long-read technology.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start22 Apr 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999096
- Sponsor's protocol ID
- 9433
- Acronym
- GenoDYT
- Status last verified
- May 2026
- First submitted
- 22 May 2025
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Value of Long-read Genome Sequencing for the Molecular Diagnosis of Dystonia: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06999096
- Acronym / sponsor ID
- GenoDYT / 9433
- Conditions
- Dystonia, Movement Disorders, Combined Dystonia, Complex Dystonia
- Keywords
- Dystonia, Genome Sequencing, Long-read Sequencing, Molecular diagnosis, Neurogenetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Apr 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 31 May 2025 (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.
Dystonia is a motor disorder caused by involuntary, intermittent, or sustained muscle contractions, leading to abnormal movements or postures. It can affect any body region and often results in significant functional disability and healthcare burden. Although its familial nature was recognized early on, the advent of high-throughput DNA sequencing has dramatically increased the identification of dystonia-associated genes. Dystonia now encompasses all modes of inheritance-autosomal dominant (e.g., TOR1A, KMT2B), autosomal recessive, X-linked, and mitochondrial-and over 100 genes have been implicated. Many forms involve structural variants (SVs) or copy number variations (CNVs), which are challenging to detect using standard short-read sequencing (srWGS).
Molecular diagnosis is essential, ending the diagnostic odyssey and enabling genetic counseling, prognosis, reproductive planning, and-in some cases-targeted therapies. For instance, GNAO1-related dystonia may respond to deep brain stimulation, while dopa-responsive dystonia benefits from levodopa.
Despite advances, srWGS has key limitations, especially for detecting repeat expansions, SVs, and phasing alleles. This likely explains the low diagnostic yield in dystonia compared to other neurological disorders, with over 70% of cases remaining unsolved.
Long-read sequencing (lrWGS), such as Oxford Nanopore technology, overcomes many of these challenges by reading native DNA fragments thousands of bases long. It enables comprehensive detection of SNVs, indels, SVs, CNVs, methylation changes, and repeat expansions-including known and newly discovered pathogenic expansions (e.g., in NOTCH2NLC). It also allows phasing without parental samples, which is crucial in recessive cases.
The investigators propose that lrWGS could significantly increase the diagnostic yield in dystonia, improving patient care, enabling appropriate genetic counseling, and paving the way for personalized treatment strategies.
Detailed description
Dystonia is a motor disorder characterized by abnormal movements and/or postures. It is caused by involuntary, intermittent, or sustained muscle contractions. Dystonia can affect all body segments, leading to highly variable and often severe functional impairment with a significant burden on healthcare systems.
The familial nature of some generalized dystonias was recognized as early as the 1940s. With the development and increased availability of high-throughput DNA sequencing technologies since the early 2010s, there has been an exponential rise in the discovery of genes associated with neurological phenotypes in which dystonia is either the main manifestation or part of a broader clinical picture. Dystonia is now known to be associated with all modes of inheritance, including autosomal dominant forms (e.g., TOR1A, KMT2B), autosomal recessive forms often presenting with complex phenotypes, X-linked dominant (e.g., WDR45) and recessive (e.g., TAF1) forms, and even mitochondrial inheritance.
To date, over 100 genes have been linked to dystonic phenotypes, highlighting the significant genetic heterogeneity of this condition. Many genetically determined dystonic syndromes are associated with structural variants (SVs) or copy number variations (CNVs), which are difficult to detect using routine short-read sequencing technologies.
Molecular diagnosis is crucial in the management of dystonia. It provides a definitive and precise diagnosis, bringing an end to the diagnostic odyssey for patients and their families. It also enables accurate genetic counseling, offering information on inheritance risks and the potential for other family members to be affected. In some cases, a molecular diagnosis directly influences therapeutic decisions. For example, pathogenic variants in GNAO1 are associated with early-onset dystonic syndromes that respond well to deep brain stimulation of the globus pallidus. Specific symptomatic treatments have been proposed for certain dystonias, such as levodopa in dopa-responsive dystonia. At the population level, identifying new genes or molecular causes can reveal novel pathogenic mechanisms and facilitate the development of animal or cellular models, paving the way for future gene therapies.
Over the past decade, the growing availability of short-read DNA sequencing technologies has enabled the simultaneous analysis of numerous dystonia-associated genes. In routine diagnostics, short-read sequencing involves fragmenting DNA into small pieces (usually a few hundred base pairs), which are then sequenced from both ends.
This approach has limitations, particularly for detecting repeat expansions that exceed the size of the sequenced fragments. These limitations may partly explain why a relatively small proportion of dystonia cases receive a molecular diagnosis compared to other neurological disorders like cerebellar ataxias or hereditary spastic paraplegias. Overall, more than 70% of dystonia patients sequenced via short-read WGS remain without a molecular diagnosis, despite strong clinical indicators of a genetic etiology.
To overcome these limitations, long-read DNA sequencing technologies have been developed. Unlike short-read methods, long-read sequencing preserves native DNA fragment sizes, which can span thousands of bases. One such approach (Oxford Nanopore) sequences DNA based on ionic current changes as the molecule passes through a nanometer-scale pore. Long-read sequencing offers several advantages. Like short-read methods, it detects small variants (SNVs and indels). However, it also excels at identifying structural variants, CNVs, methylation changes, and especially repeat expansions-key elements often missed by standard methods.
In neurogenetics, long-read sequencing has enabled the accurate detection and quantification of known repeat disorders (e.g., C9orf72 hexanucleotide expansions, RFC1), as well as the discovery of new disease-causing repeat expansions (e.g., GGC repeats in NOTCH2NLC).
It also allows phasing of alleles (cis or trans configurations) without requiring family segregation studies, which is particularly useful in recessive conditions.
Given the current diagnostic limitations of short-read sequencing, the emergence of newly identified repeat expansions, and the demonstrated advantages of long-read sequencing, the investigators hypothesize that a significant proportion of patients with undiagnosed dystonia could benefit from whole-genome long-read sequencing (lrWGS).
Such an approach could, in a single test, overcome many of the key diagnostic blind spots of short-read methods, particularly for detecting repeat expansions and structural variants. This would not only end the diagnostic odyssey for many patients, but also enable appropriate genetic counseling, access to reproductive options such as prenatal or preimplantation diagnosis, and even influence treatment strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dystonia patients without molecular diagnosis | Experimental | Diagnostic Test: Long-read whole genome sequencingLong-read genome sequencing for identification of genetic causes in dystonia patients without molecular diagnosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Index case affected by familial dystonia (≥1 first-degree relative affected) and/or sporadic early-onset dystonia (symptom onset before age 50), meeting the criteria of the PFMG-2025 program.
- Index case who has undergone short-read genome sequencing, which did not lead to a molecular diagnosis.
- Ability to understand and sign informed consent by the index case and/or their parents or legal guardians for patients under 18 years of age.
- Availability of a blood sample from the index case and at least two relatives, either affected or unaffected.
- Symptomatic or asymptomatic relative of an index case, who has also undergone short-read genome sequencing without a conclusive molecular diagnosis.
Key exclusion criteria (3 listed)
- Index case or relatives who are not affiliated with or not beneficiaries of a social security scheme.
- Index case and their parents presenting with a condition that, in the opinion of the investigator, would contraindicate participation in the study.
- Suspected non-genetic etiology (e.g., perinatal hypoxic-ischemic injury, kernicterus, history of severe head trauma or central nervous system infection).
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 |
|---|---|---|
| Long-read whole genome sequencingPseudonymized blood samples will undergo high-molecular-weight DNA extraction, followed by long-read whole-genome sequencing (lrWGS) using Oxford Nanopore technology. Index cases will be sequenced at high depth (>30X), while relatives will be multiplexed (>15X). Sequencing data will be analyzed through a dedicated bioinformatics pipeline to detect SNVs, indels, structural variants, and repeat expansions. Results will be interpreted by expert teams and discussed in monthly clinical-genetic meetings. Variants of interest will be validated by appropriate molecular techniques, and family segregation will be assessed when relevant. | Diagnostic test | Dystonia patients without molecular diagnosis |
Primary outcome
Long-read genome sequencing diagnostic rate
Time frame: 18 months
Proportion (expressed as a percentage) of families in which a causal genetic variant (classified as class 4 or 5 according to the American College of Medical Genetics and Genomics) explaining the patients' symptoms was identified through long-read genome sequencing, after no diagnosis had been reached using prior short-read genome analysis.
5 secondary outcomes
Technical issues rate
Time frame: 18 months
Proportion of activable disorders
Time frame: 24 months
New molecular causes of dystonia
Time frame: 18 months
Resolution following reanalysis of short-read whole genome sequencing data
Time frame: 18 months
Medico-economic impact of molecular diagnosis
Time frame: 24 months
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 20 May 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-read whole genome sequencing in people with Dystonia and Movement Disorders, run by University Hospital, Strasbourg, France at 4 sites in France.
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 6 inclusion and 3 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 Thomas WIRTH, Doctor (+33 3 88 12 89 19, thomas.wirth@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-read genome sequencing diagnostic rate (time frame: 18 months). 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 20 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.