Chronic Outcome Monitoring for DBS in Dystonia

NCT07244549 | Recruiting

• 1 other identifier: CCM_MDNS_COMMED-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

Dystonia is a severe movement disorder involving increased muscular activity and can be very variable. To date, the treatment of dystonia is challenging. One effective therapy is deep brain stimulation (DBS), an invasive therapy, where stimulation electrodes are inserted in deep brain regions and a continuous electrical therapy is delivered via a pacemaker. However, the optimization of the therapy is a long process, up to months and there is no immediate adaptation to different disease states. This project aims to improve DBS therapy: The first aim is to learn more about electrical brain activity that could be the feedback signal for individualized therapy. Secondly, the investigators want to gather information about the long-term development of the signal and potential hints for optimal therapy locations that could be acutely used to accelerate therapy optimization. To date, recordings mainly in lab settings, have suggested low-frequency activity as a biomarker for dystonia. Biomarkers are signals that are changed with therapy and that reflect symptom severity. Further understanding of the low-frequency biomarker for dystonia and its applicability in everyday life is one of the objectives in this study. Therefore, using a pacemaker that can also record brain activity, biomarker activity will be recorded for 12 months. At the same time, development of clinical symptoms will be assessed using an application with weekly questionnaires on symptoms and a video diary. At monthly appointments for data saving, resting state as well as motor activity during a finger tapping task will be recorded to also assess the development of side-effects, such as stimulation-induced slowing, and their biomarkers.

Conditions

Dystonia

Keywords

electrophysiology; biomarkers; deep brain stimulation; dystonia

Outcome Measures

Primary Outcomes (2)

• Amount of low-frequency band oscillatory suppression

  Local field potential recordings of pallidal neuronal activity will be recorded using the Percept neurostimulator. On the one hand, automatically preprocessed peak-biomarker activty in the low-frequency range (7.8-12 Hz) will be recorded continuously using the Chronic BrainSense function of the Percept neurostimulator for one year at a temporal resolution of 1 sample/10 min. Over time and with optimization of clinical DBS settings, low frequency dynamics will change in correlation with symptom improvement. On the other hand, at monthly recordings, local field potentials at a sampling frequency of 250 Hz will be recorded ON and OFF stimulation at various intensities up to the therapeutic stimulation intensity. After preprocessing and transformation to the time-frequency domain, low frequency activity will be compared between different therapy settings.

  monthly recordings for 12 months

• Proportion of pathological increase in beta band oscillatory activity

  Local field potential recordings of pallidal neuronal activity will be recorded using the Percept neurostimulator. On the one hand, automatically preprocessed peak-biomarker activity in the beta band (13-35 Hz) will be recorded continuously using the Chronic BrainSense function of the Percept neurostimulator for one year at a temporal resolution of 1 sample/10 min. Over time and with chronic DBS settings, beta band activity will increase in correlation with development of bradykinesia. On the other hand, at monthly recordings, local field potentials at a sampling frequency of 250 Hz will be recorded ON and OFF stimulation at various intensities up to the therapeutic stimulation intensity. After preprocessing and transformation to the time-frequency domain, beta band activity will be compared between different therapy settings.

  monthly recordings for 12 months

Secondary Outcomes (7)

• Proportion of dystonic symptom improvement in patient reported outcomes

  weekly, through study completion, up to 12 months

• Proportion of dystonic symptom improvement in kinematic video-based analysis

  weekly, through study completion, for up to 12 months

• Proportion of dystonic symptom improvement based on validated scales - Burke Fahn Marsden Dystonia Rating Scale

  monthly, through study completion, for up to 12 months

• Proportion of dystonic symptom improvement based on validated scales - Toronto Western Spasmodic Torticollis Rating Scale

  monthly, through study completion, for up to 12 months

• Proportion of non-motor symptom improvement

  weekly, through study completion, for up to 12 months

Other Outcomes (4)

• Unified Parkinson's Disease Rating Scale

  at beginning and completion of the study, up to 12 months

• Beck's Depression Inventory

  at beginning and end of study, up to 12 months

• Apathy Scale

  at beginning and end of study, up to 12 months

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with dystonia who receive pallidal deep brain stimulation with the Percept IPG in the study centers are offered to participate in the study. Since dystonia is a variable condition that might also affect young patients, also children and youths will, together with their parents/legal guardians, be informed about the study and consented as possible.

You may qualify if:

• Ability to give informed consent for the study, or in pediatric patients, legal guardian or parent willing to give informed consent
• Diagnosis of dystonia, which may be isolated or generalized
• Wish to receive surgical intervention with DBS to the internal pallidal globe (GPi)
• Decision to receive the sensing-enabled neurostimulator (Percept neurostimulator) PC/RC
• Age 5-80 years

You may not qualify if:

• Severe psychiatric disorders (BDI\>20)
• Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol
• No consent given

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Heinrich-Heine University, Duesseldorf: collaborator
• Hannover Medical School: collaborator
• Dystonia Medical Research Foundation: collaborator

Study Sites (3)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Heinrich Heine University

Düsseldorf, Nordrhein-Westfahlen, 40225, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (8)

• Feldmann LK, Lofredi R, Neumann WJ, Al-Fatly B, Roediger J, Bahners BH, Nikolov P, Denison T, Saryyeva A, Krauss JK, Faust K, Florin E, Schnitzler A, Schneider GH, Kuhn AA. Toward therapeutic electrophysiology: beta-band suppression as a biomarker in chronic local field potential recordings. NPJ Parkinsons Dis. 2022 Apr 19;8(1):44. doi: 10.1038/s41531-022-00301-2.

  PMID: 35440571 BACKGROUND

• Krause P, Mahlknecht P, Skogseid IM, Steigerwald F, Deuschl G, Erasmi R, Schnitzler A, Warnecke T, Muller J, Poewe W, Schneider GH, Vesper J, Warneke N, Eisner W, Prokop T, Muller JU, Volkmann J, Kuhn AA; Deep-Brain Stimulation for Dystonia Study Group. Long-Term Outcomes on Pallidal Neurostimulation for Dystonia: A Controlled, Prospective 10-Year Follow-Up. Mov Disord. 2025 Jun;40(6):1098-1111. doi: 10.1002/mds.30130. Epub 2025 Feb 5.

  PMID: 39907392 BACKGROUND

• Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.

  PMID: 17093249 BACKGROUND

• Ledingham D, Gibbs M, Mills R, Jenkins A, Nicholson C, Hussain MA, Baker M, Pavese N. Decoding Cervical Dystonia: Insights from Local Field Potentials in a Case Study Utilizing Open-Source Toolboxes. Mov Disord Clin Pract. 2025 Oct;12(10):1675-1678. doi: 10.1002/mdc3.70164. Epub 2025 Jun 5. No abstract available.

  PMID: 40470846 BACKGROUND

• Neumann WJ, Horn A, Ewert S, Huebl J, Brucke C, Slentz C, Schneider GH, Kuhn AA. A localized pallidal physiomarker in cervical dystonia. Ann Neurol. 2017 Dec;82(6):912-924. doi: 10.1002/ana.25095. Epub 2017 Dec 5.

  PMID: 29130551 BACKGROUND

• Peach R, Friedrich M, Fronemann L, Muthuraman M, Schreglmann SR, Zeller D, Schrader C, Krauss JK, Schnitzler A, Wittstock M, Helmers AK, Paschen S, Kuhn A, Skogseid IM, Eisner W, Mueller J, Matthies C, Reich M, Volkmann J, Ip CW. Head movement dynamics in dystonia: a multi-centre retrospective study using visual perceptive deep learning. NPJ Digit Med. 2024 Jun 18;7(1):160. doi: 10.1038/s41746-024-01140-6.

  PMID: 38890413 BACKGROUND

• Scheller U, Lofredi R, van Wijk BCM, Saryyeva A, Krauss JK, Schneider GH, Kroneberg D, Krause P, Neumann WJ, Kuhn AA. Pallidal low-frequency activity in dystonia after cessation of long-term deep brain stimulation. Mov Disord. 2019 Nov;34(11):1734-1739. doi: 10.1002/mds.27838. Epub 2019 Sep 4.

  PMID: 31483903 BACKGROUND

• van Rheede JJ, Feldmann LK, Busch JL, Fleming JE, Mathiopoulou V, Denison T, Sharott A, Kuhn AA. Diurnal modulation of subthalamic beta oscillatory power in Parkinson's disease patients during deep brain stimulation. NPJ Parkinsons Dis. 2022 Jul 8;8(1):88. doi: 10.1038/s41531-022-00350-7.

  PMID: 35804160 BACKGROUND

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea A Kuehn, MD

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Andrea A Kuehn, MD

CONTACT

0049 30 450 660 203; andrea.kuehn@charite.de

Lucia K Feldmann, MD

CONTACT

0049 30 450 660 296; lucia.feldmann@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 24, 2025
• Study Start: August 16, 2024
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: The Study Protocol will be made available upon request for potential collaborators, starting 16.08.2024 and beyond the study duration, as part of study publications and through the results section of the study registration. Analytic code will be made available through GitHub repositories along with the result publication process.

Locations

DE (3)