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क्लिनिकल ट्रायल NCT07244549 (COMMED) के लिए डिस्टोनिया वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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कार्ड दृश्य

Chronic Outcome Monitoring for DBS in Dystonia (COMMED) 25 बायोमार्कर-आधारित

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07244549 (COMMED) एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो डिस्टोनिया से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 16 अगस्त 2024 को हुई थी, और इसमें कुल 25 प्रतिभागियों के नामांकन की योजना है। शैरिटे विश्वविद्यालय, बर्लिन, जर्मनी इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 मार्च 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 24 नवंबर 2025 को अंतिम बार अपडेट की गई थी
संक्षिप्त सारांश
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, ...और दिखाएँ
विस्तृत विवरण
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 automati...और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
डिस्टोनिया
प्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:
अन्य अध्ययन आईडी
  • COMMED
  • CCM_MDNS_COMMED-01
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-08-16
अंतिम अद्यतन प्रकाशित
2025-11-24
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-03-30
नामांकन (अनुमानित)
25
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
भर्ती जारी
प्रमुख शब्द
electrophysiology
biomarkers
deep brain stimulation
dystonia
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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.
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.
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.
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.
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.
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.
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.
monthly, through study completion, for up to 12 months
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
5 Years
अध्ययन के लिए पात्र लिंग
सभी
  • 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

  • Severe psychiatric disorders (BDI>20)
  • Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol
  • No consent given
Charite University, Berlin, Germany logoशैरिटे विश्वविद्यालय, बर्लिन, जर्मनी204 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
अध्ययन उत्तरदायी पक्ष
Dr Lucia K Feldmann, मुख्य अन्वेषक, Principal Investigator, Charite University, Berlin, Germany
अध्ययन केंद्रीय संपर्क
संपर्क: Andrea A Kuehn, MD, 0049 30 450 660 203, [email protected]
संपर्क: Lucia K Feldmann, MD, 0049 30 450 660 296, [email protected]
3 1 देशों में अध्ययन स्थान

Lower Saxony

Medizinische Hochschule Hannover, Hanover, Lower Saxony, 30625, Germany
Joachim K Krauss, MD, संपर्क, 0049 511 532-6651, [email protected]
Assel Saryyeva, MD, संपर्क, 0049 511 532-6651, [email protected]
भर्ती जारी

Nordrhein-Westfahlen

Heinrich Heine University, Düsseldorf, Nordrhein-Westfahlen, 40225, Germany
Alfons Schnitzler, MD, संपर्क, 0049 211 81-08471, [email protected]
Dzhamilia Aravistka, MD, संपर्क, [email protected]
भर्ती जारी

State of Berlin

Charité Universitätsmedizin Berlin, Berlin, State of Berlin, 10117, Germany
Lucia K Feldmann, MD, संपर्क, 004930450660298, [email protected]
Jonathan Kaplan, संपर्क, 0049 30 450 560 086, [email protected]
Ana-Luisa de Almeida Marcelino, MD, उप-अन्‍वेषक
Andrea A Kuehn, MD, मुख्य अन्वेषक
Johanna Reimer, MD, उप-अन्‍वेषक
भर्ती जारी