Dystono-dyskinetic SyndromesDBS-QoLsNCT05870020
Validation of a Quality of Life Assessment Tool in Adult Generalized Dystonodyskinetic Syndromes Treated by Continuous Electrical Neuromodulation
A study testing Questionnaire (DBS-QoLs) in people with Dystono-dyskinetic Syndromes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dystono-dyskinetic Syndromes
- What is being tested?
- Questionnaire (DBS-QoLs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2023to 7 Apr 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adulte between 18 an 80 years
- Patient with a generalized dystono-dyskinetic syndrome treated by Electrical Neuromodulation Continue and follow-up in the unit
- Subject affiliated to the French social security system
Who cannot join
- non-French speaker
- patients who are physically unable to answer the questionnaire and who have no trusted person to help
- severe cognitive impairment (MoCA <10, MDRS <123, PM-38 <70)
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Quality of Life Assessment Tool in Generalized Dystonodyskinetic Syndromes Treated With Continuous Electrical Neuromodulation (CEN): The "Dystono-dyskinetic BrethoméSanrey Quality of Life" Scale (DBS-QoLs)
In spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of subjective improvement. We have been working for several years at the bedside of patients operated on in the " pathologies cérébrales résistantes " Unit on the development of a related questionnaire to assess both the motor severity and the patients' feelings about the evolution of their disease under Deep Brain Stimulation (DBS).
The self-questionnaire designed would allow to a certain extent to get away from the two gold standards currently used in the field, i.e. the Burke, Fahn \& Marsden Dystonia Rating Scale (BFMDRS) and the SF-36, thus facilitating the evaluation and allowing a homogenization of the practices for the different implanting centers on the french territory.
Read the detailed description
The construction of the tool in its particular design, including various targeted modules, stems from an experience of more than ten years acquired with patients treated by deep brain stimulation in the unit. The self-questionnaire thus obtained will be sent to 146 patients with generalized dystonodyskinetic syndrome, operated and followed in the unit, and submitted to various statistical analyses. The scores of the identified dimensions will be compared with the etiology of the abnormal movements (primary vs. secondary) as well as with the results obtained with the two scales currently used to evaluate abnormal movements (BFMDRS) and/or quality of life (SF-36) and finally with the patients' mood during their follow-up (BDI, STAI). Tolerance to surgery will also be measured.
- Conditions
- Dystono-dyskinetic Syndromes
- Being tested
- Questionnaire (DBS-QoLs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire (DBS-QoLs)Other
The DBS-QoLs questionnaire will be sent to the patients for answer:
The questonnaire will be sent at :
- the inclusion
- 15 days after the inclusion
- 1 year after the inclusion
| Study group | Role | What they receive |
|---|---|---|
| Adults with dystono-diskinetic syndrome treated by depp brain stimulation in the unit. | Experimental | Not described Receives: Other: Questionnaire (DBS-QoLs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform different activities assessed by DBS-QOLs
Ability to perform different activities assessed by the Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale (DBS-QOLs) with the evaluation of the ability to perform different activities (from impossible to autonomous) and then to estimate the evolution of this ability since the intervention (worsening, no change, improvement)
Measured: 1 year
Psycho-social assessment by DBS-QOLs
Psychosocial assessment by the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no/partially questions related to the emotional and psychological perception of patients and then to estimate the evolution of this thought since the intervention (worsening, no change, improvement)
Measured: 1 year
Intervention's assessment by DBS-QOLs
Intervention's assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no question related to the intervention.
Measured: 1 year
Life's Quality assessment by DBS-QOLs
Life's Quality assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with squales from 0 (worst case) to 10 (best case).
Measured: 1 year
Secondary outcomes (7)
External validity of the DBS-QOLs compared to the BFMDRS for the functional subscale
Correlation between the "Functional" subscale of the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the total score obtained on the Functional dimension (Mobility + Activity of Daily Living) of the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs).
Measured: 1 year
External validity of the DBS-QOLs compared to the Beck Depression Inventory score for Thumia
Correlation of the Thumia score assessed by the Beck Depression Inventory score \& the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) through the answer the the emotional and psychological perception of patients which have 12 items (Impossible, third person help, technology help, autonomous)
Measured: 1 year
External validity of the DBS-QOLs compared to the SF-36 for Life's quality
Comparison of the Life's quality assessed by the Short Form (36) Health Survey (SF-36) and by the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with different yes/no question
Measured: 1 year
External validity of the reproducibility of the DBS-QOLs compared to the BFMDRS
Comparison of the sentivity to change between the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) through the evolution of the answer of DBS-QoLs and BFMDRS during the following of the patient.
Measured: 1 year
External validity according to different clinical criteria or scales : sensitivity to change
Sensitivity to change (assessment of changes during follow-up by the BFMDRS).
Measured: 1 year
Assessment of the correlation between the functional fain & the benefit felt by the patient with the DBS-QOLs
Assessment of the correlation between the measure of benefit in terms of functional gain and the benefit experienced by the patient with all the answer of all module in "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs).
Measured: 1 year
Assessment of the tolerance to surgery by the DBS-QOLs
Assessment of the tolerance to surgery through the "surgical" module of the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) which is composed of yes/no questions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start24 May 2023
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Why it stopped: The study was discontinued at the investigator's discretion due to recruitment difficulties. In addition, patient care and management practices have evolved, and the DBS-QoL questionnaire is no longer used in routine clinical practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystono-dyskinetic SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870020
- Sponsor's protocol ID
- RECHMPL22_0228
- Acronym
- DBS-QoLs
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2023
- Last updated
- 9 Jul 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Quality of Life Assessment Tool in Generalized Dystonodyskinetic Syndromes Treated With Continuous Electrical Neuromodulation (CEN): The "Dystono-dyskinetic BrethoméSanrey Quality of Life" Scale (DBS-QoLs)
- ClinicalTrials.gov ID
- NCT05870020
- Acronym / sponsor ID
- DBS-QoLs / RECHMPL22_0228
- Conditions
- Dystono-dyskinetic Syndromes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued at the investigator's discretion due to recruitment difficulties. In addition, patient care and management practices have evolved, and the DBS-QoL questionnaire is no longer used in routine clinical practice.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 23 May 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.
In spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of subjective improvement. We have been working for several years at the bedside of patients operated on in the " pathologies cérébrales résistantes " Unit on the development of a related questionnaire to assess both the motor severity and the patients' feelings about the evolution of their disease under Deep Brain Stimulation (DBS).
The self-questionnaire designed would allow to a certain extent to get away from the two gold standards currently used in the field, i.e. the Burke, Fahn \& Marsden Dystonia Rating Scale (BFMDRS) and the SF-36, thus facilitating the evaluation and allowing a homogenization of the practices for the different implanting centers on the french territory.
Detailed description
The construction of the tool in its particular design, including various targeted modules, stems from an experience of more than ten years acquired with patients treated by deep brain stimulation in the unit. The self-questionnaire thus obtained will be sent to 146 patients with generalized dystonodyskinetic syndrome, operated and followed in the unit, and submitted to various statistical analyses. The scores of the identified dimensions will be compared with the etiology of the abnormal movements (primary vs. secondary) as well as with the results obtained with the two scales currently used to evaluate abnormal movements (BFMDRS) and/or quality of life (SF-36) and finally with the patients' mood during their follow-up (BDI, STAI). Tolerance to surgery will also be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with dystono-diskinetic syndrome treated by depp brain stimulation in the unit. | Experimental | Other: Questionnaire (DBS-QoLs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adulte between 18 an 80 years
- Patient with a generalized dystono-dyskinetic syndrome treated by Electrical Neuromodulation Continue and follow-up in the unit
- Subject affiliated to the French social security system
Key exclusion criteria (4 listed)
- non-French speaker
- patients who are physically unable to answer the questionnaire and who have no trusted person to help
- severe cognitive impairment (MoCA <10, MDRS <123, PM-38 <70)
- lack of informed consent
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 |
|---|---|---|
| Questionnaire (DBS-QoLs)The DBS-QoLs questionnaire will be sent to the patients for answer: The questonnaire will be sent at : * the inclusion * 15 days after the inclusion * 1 year after the inclusion | Other | Adults with dystono-diskinetic syndrome treated by depp brain stimulation in the unit. |
Primary outcome
Ability to perform different activities assessed by DBS-QOLs
Time frame: 1 year
Ability to perform different activities assessed by the Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale (DBS-QOLs) with the evaluation of the ability to perform different activities (from impossible to autonomous) and then to estimate the evolution of this ability since the intervention (worsening, no change, improvement)
Psycho-social assessment by DBS-QOLs
Time frame: 1 year
Psychosocial assessment by the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no/partially questions related to the emotional and psychological perception of patients and then to estimate the evolution of this thought since the intervention (worsening, no change, improvement)
Intervention's assessment by DBS-QOLs
Time frame: 1 year
Intervention's assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no question related to the intervention.
Life's Quality assessment by DBS-QOLs
Time frame: 1 year
Life's Quality assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with squales from 0 (worst case) to 10 (best case).
7 secondary outcomes
External validity of the DBS-QOLs compared to the BFMDRS for the functional subscale
Time frame: 1 year
External validity of the DBS-QOLs compared to the Beck Depression Inventory score for Thumia
Time frame: 1 year
External validity of the DBS-QOLs compared to the SF-36 for Life's quality
Time frame: 1 year
External validity of the reproducibility of the DBS-QOLs compared to the BFMDRS
Time frame: 1 year
External validity according to different clinical criteria or scales : sensitivity to change
Time frame: 1 year
Assessment of the correlation between the functional fain & the benefit felt by the patient with the DBS-QOLs
Time frame: 1 year
Assessment of the tolerance to surgery by the DBS-QOLs
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The study was discontinued at the investigator's discretion due to recruitment difficulties. In addition, patient care and management practices have evolved, and the DBS-QoL questionnaire is no longer used in routine clinical practice.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire (DBS-QoLs) in people with Dystono-dyskinetic Syndromes, run by University Hospital, Montpellier at 1 site 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 3 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: stopped early, as of the sponsor's last update on 9 Jul 2026. 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 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?
The study was stopped early (reason given: The study was discontinued at the investigator's discretion due to recruitment difficulties. In addition, patient care and management practices have evolved, and the DBS-QoL questionnaire is no longer used in routine clinical practice.). Results are not available in the source record.
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?
Ability to perform different activities assessed by DBS-QOLs (time frame: 1 year). 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 9 Jul 2026.