Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWuerzburg University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Relevant comorbidities that might interfere with study endpoints (esp. palliative disease and severe neurologic or psychiatric comorbidities).
Trial design
Design model
Crossover
Treatments tested in this trial
DBS programming
Other interventionDBS readjustment based on COMPUTER or CLINICAL program
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ComputerExperimental treatment 1 intervention
Group B: CLINICALActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 week follow-upSecondary outcomes
1
quality of life SF-36 (Short Form-36)
SF-36 questionnaire (Short Form-36): 36 items \[0-36 points, the higher the score, the worse the symptoms\]
Time frame
4 week and 8 week follow-up2
quality of life CDQ24
CDQ24 questionnaire (Craniocervical dystonia questionnaire 24): 24 items \[0-24 points, the higher the score, the worse the symptoms\]
Time frame
4 week and 8 week follow-up3
calculated energy consumption
Energy consumption by the DBS pulse generators
Time frame
Baseline visit4
time for programming
Time necessary to program the optimal DBS settings
Time frame
Baseline visitSponsors and contacts
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Wuerzburg University Hospital
Lead sponsor
BMBF (Bundes Ministerium fuer Bildung und Forschung)
Collaborator
Source ClinicalTrials.gov