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/35440571Actively Recruiting
Led by Charite University, Berlin, Germany · Updated on 2025-11-24
25
Participants Needed
3
Research Sites
N/A
Total Duration
C
Charite University, Berlin, Germany
Lead Sponsor
H
Heinrich-Heine University, Duesseldorf
Collaborating Sponsor
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
Chronic Outcome Monitoring for DBS in Dystonia
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
A
Andrea A Kuehn, MD
L
Lucia K Feldmann, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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