Actively Recruiting

Age: 5Years - 80Years
All Genders
ID07244549

Chronic Neurophysiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation

Led by Charite University, Berlin, Germany · Updated on 2025-11-24

25

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

H

Heinrich-Heine University, Duesseldorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

Dystonia is a serious movement disorder marked by increased muscle activity and variable symptoms. Treatment is challenging, and deep brain stimulation (DBS) is an invasive therapy involving electrodes placed in deep brain areas delivering continuous electrical stimulation. This study aims to improve DBS therapy by investigating electrical brain activity as a feedback signal for personalized treatment and to understand long-term biomarker development to speed up therapy optimization using advanced recording devices. The study uses a sensing-enabled neurostimulator called the Percept device to record brain activity for 12 months in patients with dystonia receiving pallidal DBS surgery. Biomarker activity, especially low-frequency signals linked to symptoms, will be monitored continuously. Monthly visits will include recording brain activity at rest and during a finger tapping task, alongside symptom assessments. Participants will use an app for weekly symptom questionnaires and video diaries to track clinical changes and treatment side effects. Participants will be monitored through regular clinical scales, neurophysiological recordings, and patient-reported outcomes over the first post-operative year. Motor and non-motor symptoms will be assessed weekly and monthly. Data collected includes continuous brain activity measurements, video-based movement analysis, and standardized scales such as the Burke-Fahn-Marsden Dystonia Rating Scale and Toronto Western Spasmodic Torticollis Rating Scale. The study duration is up to 12 months, aiming to better link biomarker changes with symptom improvement and therapy effects.

CONDITIONS

Brief Title

Chronic Outcome Monitoring for DBS in Dystonia

Who Can Participate

Age: 5Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give informed consent, or legal guardian consent for pediatric patients
  • Diagnosis of dystonia, isolated or generalized
  • Plan to receive surgical intervention with DBS to the internal pallidal globe (GPi)
  • Decision to receive the sensing-enabled Percept neurostimulator
  • Age between 5 and 80 years
Not Eligible

You will not qualify if you...

  • Severe psychiatric disorders (Beck Depression Inventory score >20)
  • Other severe medical conditions interfering with study participation
  • No consent given

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo surgical implantation of deep brain stimulation electrodes and the Percept neurostimulator device.

1 surgical visit with immediate post-operative care

Long-term Monitoring

Duration - Up to 12 months

Participants have continuous biomarker monitoring through the Percept neurostimulator device, with weekly patient-reported outcomes and kinematic video analysis, and monthly high-resolution neurophysiological recordings and clinical assessments.

Weekly visits for patient-reported outcomes and video analysis; monthly lab visits for neurophysiological recordings and clinical scales

Trial Site Locations

Total: 3 locations

1

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany, 30625

Actively Recruiting

2

Heinrich Heine University

Düsseldorf, Nordrhein-Westfahlen, Germany, 40225

Actively Recruiting

3

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

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Research Team

A

Andrea A Kuehn, MD

L

Lucia K Feldmann, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Toward therapeutic electrophysiology: beta-band suppression as a biomarker in chronic local field potential recordings.

Lucia K Feldmann, Roxanne Lofredi, Wolf-Julian Neumann...

https://pubmed.ncbi.nlm.nih.gov/35440571

Long-Term Outcomes on Pallidal Neurostimulation for Dystonia: A Controlled, Prospective 10-Year Follow-Up.

Patricia Krause, Philipp Mahlknecht, Inger Marie Skogseid...

https://pubmed.ncbi.nlm.nih.gov/39907392

Decoding Cervical Dystonia: Insights from Local Field Potentials in a Case Study Utilizing Open-Source Toolboxes.

David Ledingham, Michelle Gibbs, Russell Mills...

https://pubmed.ncbi.nlm.nih.gov/40470846

Head movement dynamics in dystonia: a multi-centre retrospective study using visual perceptive deep learning.

Robert Peach, Maximilian Friedrich, Lara Fronemann...

https://pubmed.ncbi.nlm.nih.gov/38890413

Diurnal modulation of subthalamic beta oscillatory power in Parkinson's disease patients during deep brain stimulation.

Joram J van Rheede, Lucia K Feldmann, Johannes L Busch...

https://pubmed.ncbi.nlm.nih.gov/35804160