Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT02097693
Brief Summary:
There are limited therapeutical options for patients with secondary dystonia due to cerebral palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep brain stimulation (DBS) has proven to be a safe and effective therapy for patients with parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with dyskinetic cerebral palsy are limited with heterogeneous data.
With STIM-CP we investigate the effect of DBS on quality of life in young patients with a dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain injury. Additionally, the effect of DBS on motor development, speech, memory, attention, cognition and pain perception will be assessed.
Detailed Description:
In total, 20 patients aged 7-18 years diagnosed with dyskinetic cerebral palsy due to perinatal asphyxia, who will receive DBS, should be included. 11 German DBS-centres will participate in the trial. Effects of DBS will be assessed up to 36 months after Initial Implantation.
There are two preoperative visits (screening and baseline) and nine postoperative visits (implantation, 3-, 6-, 9-, 12-, 24- and 36-moths follow-up). We assume that DBS reduces the severity of dystonia and improves the quality of life in these patients.
Study:
NCT02097693
Study Brief:
Protocol Section:
NCT02097693