Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy

NCT02097693 | Completed DMC

• 1 other identifier: Uni-Koeln-1603
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia

Keywords

DBS; quality of life; dystonia; dyskinetic cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)

  Difference in CPCHILD before and 36 months on DBS (response=improvement \> 10%)

  CPCHILD 12 months after DBS

Secondary Outcomes (15)

• Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability

  0, 6, 12, 24 and 36 months after DBS

• Dyskinesia Impairment Scale

  0, 12, 24 and 36 months

• Tardieu Scale

  0 and 12 months after DBS

• Frenchay Dysarthria Assessment

  0, 12, 24 and 36 months after DBS

• SF-36

  0, 6, 12, 24 and 36 months after DBS

Study Arms (1)

dyston-dyskinetic cerebral palsy

Young patients with dyston-dyskinetic cerebral palsy who receive DBS in the GPi

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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
• Informed consent to take part in the study from patient and/or legal representative if the patient is underaged or not capable to give consent himself
• Patient and/or legal representative if the patient is underaged or not capable to give consent himself, understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed

You may not qualify if:

• 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
• Any history of frequent grand-mal seizures without response to anticonvulsive treatment
• Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device.
• Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
• A history of neurostimulation intolerance in any area of the body.
• Currently on any anticoagulant medications that cannot be discontinued during perioperative period.

Sponsors & Collaborators

• University Hospital of Cologne: lead
• University Hopsital Schleswig Holstein Campus Lübeck: collaborator
• Boston Scientific Corporation: collaborator
• University Hsopital of Magdeburg: collaborator
• University Hospital of Munich: collaborator
• Schoen Klinik Vogtareuth: collaborator
• University Hospital of Tübingen: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Hannover Medical School: collaborator
• University Hospital of Kiel: collaborator
• University Hospital of Würzburg: collaborator
• University Hospital of Freiburg: collaborator
• University Hospital Berlin Charite: collaborator

Study Sites (1)

University Hospital Cologne

Cologne, Northern Westfalia, 50935, Germany

Location

Related Publications (1)

• Koy A, Kuhn AA, Huebl J, Schneider GH, van Riesen AK, Eckenweiler M, Rensing-Zimmermann C, Coenen VA, Krauss JK, Saryyeva A, Hartmann H, Haeussler M, Volkmann J, Matthies C, Horn A, Schnitzler A, Vesper J, Gharabaghi A, Weiss D, Bevot A, Marks W, Pomykal A, Monbaliu E, Borck G, Mueller J, Prinz-Langenohl R, Dembek T, Visser-Vandewalle V, Wirths J, Schiller P, Hellmich M, Timmermann L; STIM-CP investigators. Quality of Life After Deep Brain Stimulation of Pediatric Patients with Dyskinetic Cerebral Palsy: A Prospective, Single-Arm, Multicenter Study with a Subsequent Randomized Double-Blind Crossover (STIM-CP). Mov Disord. 2022 Apr;37(4):799-811. doi: 10.1002/mds.28898. Epub 2021 Dec 29.

  PMID: 34967053 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-plasma for DYT1-testing

MeSH Terms

Conditions

Dystonia; Cerebral Palsy

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Anne Koy, MD

  University Hospital Cologne, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med. Anne Koy

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: March 4, 2014
• Primary Completion: March 10, 2020
• Study Completion: December 31, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

DE (1)