Dystonia Image-based Programming of Stimulation: A Prospective, Randomized, Double-blind Crossover Trial

NCT05097001 | Recruiting DMC

• 1 other identifier: DIPS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dystonia; Deep Brain Stimulation

Outcome Measures

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.

  8 week follow-up

Secondary Outcomes (4)

• quality of life SF-36 (Short Form-36)

  4 week and 8 week follow-up

• quality of life CDQ24

  4 week and 8 week follow-up

• calculated energy consumption

  Baseline visit

• time for programming

  Baseline visit

Study Arms (2)

Computer

EXPERIMENTAL

Programming based on computer-guided assessment

Other: DBS programming

CLINICAL

ACTIVE COMPARATOR

Programming based on clinically-guided assessment

Other: DBS programming

Interventions

DBS programming OTHER

DBS readjustment based on COMPUTER or CLINICAL program

CLINICAL; Computer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Relevant comorbidities that might interfere with study endpoints (esp. palliative disease and severe neurologic or psychiatric comorbidities).

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• BMBF (Bundes Ministerium fuer Bildung und Forschung): collaborator

Study Sites (1)

Department of Neurology, University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 34924027 DERIVED

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Reich

  Department of Neurology - University Hosiptal Würzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Reich, Dr.

CONTACT

0931-201-0; Reich_M1@ukw.de

Florian Lange, Dr.

CONTACT

0931-201-0; Lange_L@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 27, 2021
• Study Start: November 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

DE (1)