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Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy | Clinical Trials | Clareo Health

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Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy

Effect of Deep Brain Stimulation in the Globus Pallidus Internus on Quality of Life in Young Patients With Dyston-dyskinetic Cerebral Palsy

NCT02097693•University Hospital of Cologne

View on ClinicalTrials.gov

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.

Eligibility

Age

7 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The treating physician has chosen GPi-DBS for the treatment of the secondary dystonia caused by cere-bral palsy in this patient
•Patient and/or legal representative, if the patient is underaged or not capable to give consent himself, have chosen GPi-DBS as treatment
•The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required
•Age at enrolment 7-18 years
•Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury
•Anti-dystonic pharmacotherapy insufficient (e.g. Jankovic J. Medical treatment of dystonia. Movement disorders, Vol. 28, No. 7, 2013) 67
•Stable anti-dystonic medication over the last 30 days
•Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible)
•No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention
•Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study
+2 more criteria

Exclusion Criteria

•• Patients with known primary (e.g. DYT1) or idiopathic dystonia
•* Severe axial hypotonia with total loss of head control (e.g. absence of control at "upper thoracic level" in the SATCo score) (medication effect excluded)
•* Fixed hemi-dystonia
•* Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale \>3)
•* Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention
•* Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)
•* Condition likely to require use of MRI in the future
•* Any intracranial abnormality or medical condition that would contraindicate DBS surgery
•* Any findings in neuropsychological screening assessments that would contraindicate DBS surgery
•* Any current drug and / or alcohol abuse
+8 more criteria

Locations (1)

University Hospital Cologne

Cologne, Northern Westfalia, Germany

Key Dates

Start Date

March 4, 2014

Primary Completion Date

March 10, 2020

Completion Date

December 31, 2021

Last Updated

March 30, 2025

Enrollment

ACTUAL participants

Conditions

Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia