DystoniaDIPSNCT05097001
Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial
A study testing DBS programming in people with Dystonia and Deep Brain Stimulation, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The primary objective of this exploratory study is to prospectively evaluate the feasibility of image-guided programming of pallidal deep brain stimulation (DBS) for dystonia. The dystonias are a heterogeneous group of movement disorders that share the core clinical feature of abnormal involuntary muscle contractions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonia, Deep Brain Stimulation
- What is being tested?
- DBS programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2021to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic deep brain stimulation (> 1 year) in the internal globus pallidus in patients with isolated dystonia.
- Deep brain stimulation settings and dystonia medication stable for > 3 months.
- Understanding about and consent to the study and signed informed consent form.
Who cannot join
- Relevant comorbidities that might interfere with study endpoints (esp. palliative disease and severe neurologic or psychiatric comorbidities).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Würzburg
Würzburg, Bavaria, 97080
Martin Reich, Dr., 0931 201-0, Reich_M1@ukw.de
Florian Lange, Dr., 0931 201-0, Lange_L@ukw.de
About this study
The primary objective of this exploratory study is to prospectively evaluate the feasibility of image-guided programming of pallidal deep brain stimulation (DBS) for dystonia. The dystonias are a heterogeneous group of movement disorders that share the core clinical feature of abnormal involuntary muscle contractions in common. Pallidal DBS is an established therapy for severe cases with an average improvement in dystonia severity of 50-60%. However, outcomes are variable and difficult to predict, and clinical trials report up to 25% of Nonresponders. Variability in electrode placement and inappropriate stimulation settings may account for much of this variability in outcome. In addition, improvement in dystonia is delayed, often days to weeks after a change in DBS therapy, complicating programming.
Our group recently developed a computer model to predict optimal individualized stimulation settings in patients based on the outcome of a large cohort of of chronically treated patients. In-silico testing showed a 16.3% better mean group improvement with computer-assisted programming compared with physician-assisted programming and a dramatic reduction in non-responders (from 25% to 5%).
In this prospective study, the computer model will be compared in a randomized, controlled, and double blinded setting against best clinical DBS programming. The primary outcome will be a responder analysis in which dystonia severity will be compared between conventional clinical and model-based programming will be compared.
Read the detailed description
Dystonia is a neurological syndrome characterized by involuntary, sustained, or repetitive muscle contractions of opposing muscle groups that cause twisting movements and abnormal postures. Dystonias meet the prevalence criterion of a rare disorder, with prevalence estimates ranging from 0.2-5/100,000 for infantile or juvenile forms to 3-732/100,000 for dystonias manifesting in adults. In addition to motor impairments and mobility limitations, patients - especially young patients - suffer from non-motor symptoms: depression (> 15%), anxiety (> 25%), decreased sleep quality (> 70%), and pain (> 75%). In addition, there is a high risk of economic impairment, including job loss (> 55%), and decreased productivity are serious social consequences (> 50%). However, disability is usually secondary to motor impairment, and adequate treatment of motor symptoms can lead to profound improvements in quality of life (Skogseid et al. 2007). Currently, there is no cure for dystonia, and pharmacological symptom treatment is limited. Deep brain stimulation (DBS) of the internal globus pallidus (GPi) is a recommended therapy for severe dystonia with Class I evidence for safety and efficacy (Vidailhet et al. 2005; Volkmann et al. 2012; Volkmann et al. 2014). However, clinical trials report up to 25% non-responders (<25% motor improvement) (Volkmann et al. 2012; Volkmann et al. 2014). Variability in electrode placement and inappropriate stimulation settings may explain much of this outcome variability (Reich et al. 2019). In addition, dystonia improves with a delay, often weeks after initiation or days after switching neurostimulation therapy, complicating clinical programming for DBS (Kupsch et al. 2011). Our group recently presented a novel approach based on empirical knowledge from a large cohort of chronically treated patients. We defined probabilistic maps of antidystonic effects using electrode position and volumes of tissue activation (VTA) from >100 patients. This method predicts a 16.3% better mean group improvement with computer-selected electrode choices compared with physician programming and a reduced proportion of non-responders from 25% to <5% (Reich et al. 2019). This potential advantage of computer-assisted programming capabilities will be tested in the study described here.
This study is supported by the Bundesministerium für Bildung und Forschung (BMBF): Förderkennzeichen: 01KG2032
- Conditions
- Dystonia, Deep Brain Stimulation
- Being tested
- DBS programming
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS programmingOther
DBS readjustment based on COMPUTER or CLINICAL program
| Study group | Role | What they receive |
|---|---|---|
| Computer | Experimental | Programming based on computer-guided assessment Receives: Other: DBS programming |
| CLINICAL | Active comparator | Programming based on clinically-guided assessment Receives: Other: DBS programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful treatment with model predicted settings
The primary efficacy endpoint is based on the blinded physician rating of dystonia severity reflected by Clinical Dystonia Rating Scales (BFMDRS or TWSTRS). The raters will be internationally recognized leading experts in the field of movement disorders that are not part of the study team or otherwise related to our center. For both interventions (best clinical settings and model predicted settings) we will calculate the symptom severity score after 4 weeks of continuous stimulation, expressed in percent of the pre-operative score. The primary endpoint is defined as "successful treatment with model predicted settings" (yes or no). The value is "yes" if the motor symptoms with model predicted settings are equal or better (tolerance 5%) to clinical settings.
Measured: 8 week follow-up
Secondary outcomes (4)
quality of life SF-36 (Short Form-36)
SF-36 questionnaire (Short Form-36): 36 items [0-36 points, the higher the score, the worse the symptoms]
Measured: 4 week and 8 week follow-up
quality of life CDQ24
CDQ24 questionnaire (Craniocervical dystonia questionnaire 24): 24 items [0-24 points, the higher the score, the worse the symptoms]
Measured: 4 week and 8 week follow-up
calculated energy consumption
Energy consumption by the DBS pulse generators
Measured: Baseline visit
time for programming
Time necessary to program the optimal DBS settings
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Nov 2021
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
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 DystoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BMBF (Bundes Ministerium fuer Bildung und Forschung)
- Responsible party
- Sponsor
- Investigators
- Martin Reich, Principal investigator, Department of Neurology - University Hosiptal Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097001
- Sponsor's protocol ID
- DIPS
- Acronym
- DIPS
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lange F, Roothans J, Wichmann T, Gelbrich G, Roser C, Volkmann J, Reich M. DIPS (Dystonia Image-based Programming of Stimulation: a prospective, randomized, double-blind crossover trial). Neurol Res Pract. 2021 Dec 20;3(1):65. doi: 10.1186/s42466-021-00165-6.
PubMed 34924027
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial
- ClinicalTrials.gov ID
- NCT05097001
- Acronym / sponsor ID
- DIPS / DIPS
- Conditions
- Dystonia, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- BMBF (Bundes Ministerium fuer Bildung und Forschung)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Oct 2021 (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.
The primary objective of this exploratory study is to prospectively evaluate the feasibility of image-guided programming of pallidal deep brain stimulation (DBS) for dystonia. The dystonias are a heterogeneous group of movement disorders that share the core clinical feature of abnormal involuntary muscle contractions in common. Pallidal DBS is an established therapy for severe cases with an average improvement in dystonia severity of 50-60%. However, outcomes are variable and difficult to predict, and clinical trials report up to 25% of Nonresponders. Variability in electrode placement and inappropriate stimulation settings may account for much of this variability in outcome. In addition, improvement in dystonia is delayed, often days to weeks after a change in DBS therapy, complicating programming.
Our group recently developed a computer model to predict optimal individualized stimulation settings in patients based on the outcome of a large cohort of of chronically treated patients. In-silico testing showed a 16.3% better mean group improvement with computer-assisted programming compared with physician-assisted programming and a dramatic reduction in non-responders (from 25% to 5%).
In this prospective study, the computer model will be compared in a randomized, controlled, and double blinded setting against best clinical DBS programming. The primary outcome will be a responder analysis in which dystonia severity will be compared between conventional clinical and model-based programming will be compared.
Detailed description
Dystonia is a neurological syndrome characterized by involuntary, sustained, or repetitive muscle contractions of opposing muscle groups that cause twisting movements and abnormal postures. Dystonias meet the prevalence criterion of a rare disorder, with prevalence estimates ranging from 0.2-5/100,000 for infantile or juvenile forms to 3-732/100,000 for dystonias manifesting in adults. In addition to motor impairments and mobility limitations, patients - especially young patients - suffer from non-motor symptoms: depression (> 15%), anxiety (> 25%), decreased sleep quality (> 70%), and pain (> 75%). In addition, there is a high risk of economic impairment, including job loss (> 55%), and decreased productivity are serious social consequences (> 50%). However, disability is usually secondary to motor impairment, and adequate treatment of motor symptoms can lead to profound improvements in quality of life (Skogseid et al. 2007). Currently, there is no cure for dystonia, and pharmacological symptom treatment is limited. Deep brain stimulation (DBS) of the internal globus pallidus (GPi) is a recommended therapy for severe dystonia with Class I evidence for safety and efficacy (Vidailhet et al. 2005; Volkmann et al. 2012; Volkmann et al. 2014). However, clinical trials report up to 25% non-responders (<25% motor improvement) (Volkmann et al. 2012; Volkmann et al. 2014). Variability in electrode placement and inappropriate stimulation settings may explain much of this outcome variability (Reich et al. 2019). In addition, dystonia improves with a delay, often weeks after initiation or days after switching neurostimulation therapy, complicating clinical programming for DBS (Kupsch et al. 2011). Our group recently presented a novel approach based on empirical knowledge from a large cohort of chronically treated patients. We defined probabilistic maps of antidystonic effects using electrode position and volumes of tissue activation (VTA) from >100 patients. This method predicts a 16.3% better mean group improvement with computer-selected electrode choices compared with physician programming and a reduced proportion of non-responders from 25% to <5% (Reich et al. 2019). This potential advantage of computer-assisted programming capabilities will be tested in the study described here.
This study is supported by the Bundesministerium für Bildung und Forschung (BMBF): Förderkennzeichen: 01KG2032
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer | Experimental | Other: DBS programmingProgramming based on computer-guided assessment |
| CLINICAL | Active comparator | Other: DBS programmingProgramming based on clinically-guided assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic deep brain stimulation (> 1 year) in the internal globus pallidus in patients with isolated dystonia.
- Deep brain stimulation settings and dystonia medication stable for > 3 months.
- Understanding about and consent to the study and signed informed consent form.
Key exclusion criteria (1 listed)
- Relevant comorbidities that might interfere with study endpoints (esp. palliative disease and severe neurologic or psychiatric comorbidities).
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 |
|---|---|---|
| DBS programmingDBS readjustment based on COMPUTER or CLINICAL program | Other | CLINICAL, Computer |
Primary outcome
successful treatment with model predicted settings
Time frame: 8 week follow-up
The primary efficacy endpoint is based on the blinded physician rating of dystonia severity reflected by Clinical Dystonia Rating Scales (BFMDRS or TWSTRS). The raters will be internationally recognized leading experts in the field of movement disorders that are not part of the study team or otherwise related to our center. For both interventions (best clinical settings and model predicted settings) we will calculate the symptom severity score after 4 weeks of continuous stimulation, expressed in percent of the pre-operative score. The primary endpoint is defined as "successful treatment with model predicted settings" (yes or no). The value is "yes" if the motor symptoms with model predicted settings are equal or better (tolerance 5%) to clinical settings.
4 secondary outcomes
quality of life SF-36 (Short Form-36)
Time frame: 4 week and 8 week follow-up
quality of life CDQ24
Time frame: 4 week and 8 week follow-up
calculated energy consumption
Time frame: Baseline visit
time for programming
Time frame: Baseline visit
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 28 Jan 2025.
- Derived from this study: PubMed 34924027Lange F, Roothans J, Wichmann T, Gelbrich G, Roser C, Volkmann J, Reich M. DIPS (Dystonia Image-based Programming of Stimulation: a prospective, randomized, double-blind crossover trial). Neurol Res Pract. 2021 Dec 20;3(1):65. doi: 10.1186/s42466-021-00165-6.
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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.
Martin Reich principal investigator
Department of Neurology - University Hosiptal Würzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS programming in people with Dystonia and Deep Brain Stimulation, run by Wuerzburg University Hospital 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 1 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 28 Jan 2025. 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?
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 Martin Reich, Dr. (0931-201-0, Reich_M1@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful treatment with model predicted settings (time frame: 8 week follow-up). 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 NCT05097001, 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 Jan 2025.