DystoniaCOMMEDNCT07244549
Chronic Outcome Monitoring for DBS in Dystonia
An observational study of Dystonia, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Dystonia
- How many people
- 25 participants
- Where
- 3 sitesGermany
- Study dates
- 16 Aug 2024to 30 Mar 2028
- Phase
- Observational
- 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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Severe psychiatric disorders (BDI>20)
- Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol
- No consent given
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Lucia K Feldmann, MD, 004930450660298, lucia.feldmann@charite.de
Jonathan Kaplan, 0049 30 450 560 086, jonathan.kaplan@charite.de
- Recruiting
Heinrich Heine University
Düsseldorf, Nordrhein-Westfahlen, 40225
Alfons Schnitzler, MD, 0049 211 81-08471, SchnitzA@med.uni-duesseldorf.de
Dzhamilia Aravistka, MD, dzhamilia.aravitska@med.uni-duesseldorf.de
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Joachim K Krauss, MD, 0049 511 532-6651, Krauss.Joachim@mh-hannover.de
Assel Saryyeva, MD, 0049 511 532-6651, Assel.Saryyeva@mh-hannover.de
About this study
Official title: Chronic Neurophyhsiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation
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.
Read the detailed description
Dystonia is a hyperkinetic movement disorder that can have various clinical phenotypes, from isolated cervical dystonia to severe generalized dystonia. Deep brain stimulation (DBS) is an effective therapy for dystonic symptoms and has been successfully used for more than 20 years. However, clinical optimization can be a complicated and lengthy process, and to date there is no closed-loop stimulation paradigm automatically adapting to current disease states.
Previous electrophysiological research using intracranial local field potential (LFP) recordings from DBS electrodes in the internal pallidal globe (GPi) has identified low-frequency activity in the theta/alpha band (7-12 Hz) as a physiomarker for symptom severity, although stimulation effects on the neurophysiology have only been investigated indirectly to date. Interestingly, stimulation-induced bradykinesia was correlated with increased beta-band activity, pointing towards transdiagnostic biomarkers. With the Percept neurostimulator (Medtronic Inc., Minnesota, USA) high resolution electrophysiological recordings, also during stimulation, and chronic biomarker tracking have become more accessible, also allowing for investigation of long-term dynamics such as circadian variations. To date, in dystonia, only case-reports have been published using this device.
Here, the development of electrophysiological biomarkers are systematically investigated during the first post-operative year. The aim is to, firstly, characterize the potential of low-frequency activity as a biomarker for adaptive algorithms. Secondly, neurophysiological signatures (e.g. low-frequency, gamma band activity) that are predictive of symptom improvement will be characterized, which might lead to electrophysiology-guided acceleration of therapy optimization.
All patients with dystonia, regardless of the dystonia type, between the age of 5-80 years, receiving surgery for pallidal deep brain stimulation electrode implantation and the Percept device are screened to participate in the study. Participants, and if applicable the legal guardians, will provide informed consent according to the ethics approval (EA1/164/23 and EA2/163/25). The aim is to include 20-30 patients with various types of dystonia.
The first dataset will be continuously recorded biomarker activity in the low-frequency range and beta band, to also assess development of stimulation-induced beta increases. Recordings will be done using the Percept Chronic BrainSense feature that allows for continuous assessment of peak biomarker activity at an investigator-selected peak at a 5 Hz window and a temporal resolution of one mean value/10min. For symptomatic correlation, subjective (patient reported outcome (PRO) questionnaire) and objective (video-based kinematic analysis) will be collected. The PRO will cover motor symptoms as well as non-motor symptoms such as mood and pain.
The second data set will be high-resolution local-field potential recordings at monthly lab visits. Here, different therapy states (ON/OFF DBS) will be recorded during rest (comfortably seated with open eyes) and a movement task (finger tapping). Additionally, standardized clinical scales such as the Burke-Fahn-Marsden-Dystonia-Rating Scale (BFMDRS) and the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) will be assessed by clinicians.
- Conditions
- Dystonia
- Keywords
- electrophysiology, biomarkers, deep brain stimulation, dystonia
- Medical subject headings
- Dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: monthly recordings for 12 months
Secondary outcomes (7)
Proportion of dystonic symptom improvement in patient reported outcomes
Weekly patient reported outcomes focused on motor symptoms (4 items: general movement, walking, use of hands, neck muscle tenseness) will provide insights into subjective evaluation of participants, on a 9-points likert scale. Lower scores imply improved symptoms.
Measured: weekly, through study completion, up to 12 months
Proportion of dystonic symptom improvement in kinematic video-based analysis
Based on weekly video recordings or at least monthly recordings at the lab visits, automated models will be used to assess symptom severity. With DBS optimization, an improvement of symptom severity is expected, that can be objectified in video kinematics as angle of deviation from midline, smaller angles imply reduced deviation and symptom improvement.
Measured: weekly, through study completion, for up to 12 months
Proportion of dystonic symptom improvement based on validated scales - Burke Fahn Marsden Dystonia Rating Scale
At the monthly recordings, trained clinicians and movement disorder specialists will assess the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS), lower scores indicate symptom improvement.
Measured: monthly, through study completion, for up to 12 months
Proportion of dystonic symptom improvement based on validated scales - Toronto Western Spasmodic Torticollis Rating Scale
At the monthly recordings, trained clinicians and movement disorder specialists will assess Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) in patients with cervical dystonia, lower scores indicate symptom improvement.
Measured: monthly, through study completion, for up to 12 months
Proportion of non-motor symptom improvement
Weekly patient reported outcome questionnaires focused on non-motor symptoms, specifically on the symptoms wellbeing, mood, pain, stress, sleep, will provide insights into subjective evaluation of non motor symptoms, rated on a 9-points likert scale. Higher scores imply improved symptoms.
Measured: weekly, through study completion, for up to 12 months
Rate of bradykinesia with velocity decrease
At the monthly recordings, finger tapping will be objectively recorded using accelerometry. With chronic DBS, the velocity of the tapping (m/s^2) will decrease.
Measured: weekly, through study completion, for up to 12 months
Rate of bradykinesia with decreased acceleration
At the monthly recordings, finger tapping will be objectively recorded using accelerometry. With chronic DBS, the acceleration (g) in the measured accelerometry data will decrease.
Measured: monthly, through study completion, for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start16 Aug 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, Hannover Medical School, Dystonia Medical Research Foundation
- Responsible party
- Principal investigator, Dr Lucia K Feldmann, Charite University, Berlin, Germany
- Investigators
- Andrea A Kuehn, MD, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244549
- Sponsor's protocol ID
- CCM_MDNS_COMMED-01
- Acronym
- COMMED
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared upon reasonable requests and after completion of data sharing contracts through the Charité GDPR-approved data management platform Virtual Research Environment.
Publications
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.
PubMed 35440571Krause 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.
PubMed 39907392Kupsch 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.
PubMed 17093249Ledingham 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.
PubMed 40470846Neumann 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.
PubMed 29130551Peach 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.
PubMed 38890413Scheller 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.
PubMed 31483903van 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.
PubMed 35804160
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Neurophyhsiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT07244549
- Acronym / sponsor ID
- COMMED / CCM_MDNS_COMMED-01
- Conditions
- Dystonia
- Keywords
- electrophysiology, biomarkers, deep brain stimulation, dystonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, Hannover Medical School, Dystonia Medical Research Foundation
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 24 Nov 2025 (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.
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.
Detailed description
Dystonia is a hyperkinetic movement disorder that can have various clinical phenotypes, from isolated cervical dystonia to severe generalized dystonia. Deep brain stimulation (DBS) is an effective therapy for dystonic symptoms and has been successfully used for more than 20 years. However, clinical optimization can be a complicated and lengthy process, and to date there is no closed-loop stimulation paradigm automatically adapting to current disease states.
Previous electrophysiological research using intracranial local field potential (LFP) recordings from DBS electrodes in the internal pallidal globe (GPi) has identified low-frequency activity in the theta/alpha band (7-12 Hz) as a physiomarker for symptom severity, although stimulation effects on the neurophysiology have only been investigated indirectly to date. Interestingly, stimulation-induced bradykinesia was correlated with increased beta-band activity, pointing towards transdiagnostic biomarkers. With the Percept neurostimulator (Medtronic Inc., Minnesota, USA) high resolution electrophysiological recordings, also during stimulation, and chronic biomarker tracking have become more accessible, also allowing for investigation of long-term dynamics such as circadian variations. To date, in dystonia, only case-reports have been published using this device.
Here, the development of electrophysiological biomarkers are systematically investigated during the first post-operative year. The aim is to, firstly, characterize the potential of low-frequency activity as a biomarker for adaptive algorithms. Secondly, neurophysiological signatures (e.g. low-frequency, gamma band activity) that are predictive of symptom improvement will be characterized, which might lead to electrophysiology-guided acceleration of therapy optimization.
All patients with dystonia, regardless of the dystonia type, between the age of 5-80 years, receiving surgery for pallidal deep brain stimulation electrode implantation and the Percept device are screened to participate in the study. Participants, and if applicable the legal guardians, will provide informed consent according to the ethics approval (EA1/164/23 and EA2/163/25). The aim is to include 20-30 patients with various types of dystonia.
The first dataset will be continuously recorded biomarker activity in the low-frequency range and beta band, to also assess development of stimulation-induced beta increases. Recordings will be done using the Percept Chronic BrainSense feature that allows for continuous assessment of peak biomarker activity at an investigator-selected peak at a 5 Hz window and a temporal resolution of one mean value/10min. For symptomatic correlation, subjective (patient reported outcome (PRO) questionnaire) and objective (video-based kinematic analysis) will be collected. The PRO will cover motor symptoms as well as non-motor symptoms such as mood and pain.
The second data set will be high-resolution local-field potential recordings at monthly lab visits. Here, different therapy states (ON/OFF DBS) will be recorded during rest (comfortably seated with open eyes) and a movement task (finger tapping). Additionally, standardized clinical scales such as the Burke-Fahn-Marsden-Dystonia-Rating Scale (BFMDRS) and the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) will be assessed by clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Severe psychiatric disorders (BDI>20)
- Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol
- No consent given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of low-frequency band oscillatory suppression
Time frame: monthly recordings for 12 months
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.
Proportion of pathological increase in beta band oscillatory activity
Time frame: monthly recordings for 12 months
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.
7 secondary outcomes
Proportion of dystonic symptom improvement in patient reported outcomes
Time frame: weekly, through study completion, up to 12 months
Proportion of dystonic symptom improvement in kinematic video-based analysis
Time frame: weekly, through study completion, for up to 12 months
Proportion of dystonic symptom improvement based on validated scales - Burke Fahn Marsden Dystonia Rating Scale
Time frame: monthly, through study completion, for up to 12 months
Proportion of dystonic symptom improvement based on validated scales - Toronto Western Spasmodic Torticollis Rating Scale
Time frame: monthly, through study completion, for up to 12 months
Proportion of non-motor symptom improvement
Time frame: weekly, through study completion, for up to 12 months
Rate of bradykinesia with velocity decrease
Time frame: weekly, through study completion, for up to 12 months
Rate of bradykinesia with decreased acceleration
Time frame: monthly, through study completion, for up to 12 months
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 24 Nov 2025.
- Background: PubMed 35440571Feldmann 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.
- Background: PubMed 39907392Krause 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.
- Background: PubMed 17093249Kupsch 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.
- Background: PubMed 40470846Ledingham 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.
- Background: PubMed 29130551Neumann 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.
- Background: PubMed 38890413Peach 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.
- Background: PubMed 31483903Scheller 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.
- Background: PubMed 35804160van 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared upon reasonable requests and after completion of data sharing contracts through the Charité GDPR-approved data management platform Virtual Research Environment.
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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.
Andrea A Kuehn, MD study director
Charite University, Berlin, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by Charite University, Berlin, Germany at 3 sites 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 5 inclusion and 3 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Andrea A Kuehn, MD (0049 30 450 660 203, andrea.kuehn@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of low-frequency band oscillatory suppression (time frame: monthly recordings for 12 months). The study lists 2 primary outcomes in all. 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 NCT07244549, which also lists 8 linked publications.
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 24 Nov 2025.