Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy (STIM-CP)

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

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.

Study Overview

• Status: Completed
• Conditions: Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Germany
  • Northern Westfalia
    • Cologne, Northern Westfalia, Germany, 50935
      • University Hospital Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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
• 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

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
  • 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.
  • Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
  • Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator.
  • A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all forms of hormonal contraception ("antibaby-pill", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
dyston-dyskinetic cerebral palsy; Young patients with dyston-dyskinetic cerebral palsy who receive DBS in the GPi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability	Assessment of the severity of dystonia	0, 6, 12, 24 and 36 months after DBS
Dyskinesia Impairment Scale	Assessment of the severity of chorea and dystonia	0, 12, 24 and 36 months
Tardieu Scale	Assessment of the severity of spasticity	0 and 12 months after DBS
Frenchay Dysarthria Assessment	Assessment of speech and swallowing	0, 12, 24 and 36 months after DBS
SF-36	Assessment of Quality of life	0, 6, 12, 24 and 36 months after DBS
Strengths and Difficulties Questionnaire	Assessment of mood and attention	0, 6, 12, 24 and 36 months after DBS
Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R)	Assessment of Cognition	0 and 12 months
Attentional Network Test (ANT)	Assessment of Attention	0 and 12 months after DBS
Non-Verbal-Learning Test (NVLT)	Assessment of cognition	0 and 12 months after DBS
Wong Baker Faces	Assessment of pain	0, 6, 12, 24 and 36 months after DBS
Family Scale (FaBel)	Assessment of the burden for caregivers	0, 6, 12, 24 and 36 months after DBS
Canadian Occupational Performance Measure (COPM)	Assessment of activities of daily living	COPM 0 and 12 months after DBS
Gross Motor Function Measure (GMFM-66)	Assessment of physical disability	GMFM-66 0 and 12 months after DBS
Gross Motor Function Classification System (GMFCS)	Degree of physical impairment	GMFCS 0, 12, 24 and 36 months after DBS
Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)	Assessment of quality of life	0, 6, 24 and 36 months after DBS

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Hannover Medical School; Heinrich-Heine University, Duesseldorf; Boston Scientific Corporation; University Hopsital Schleswig Holstein Campus Lübeck; University Hsopital of Magdeburg; University Hospital of Munich; Schoen Klinik Vogtareuth; University Hospital of Tübingen; University Hospital of Kiel; University Hospital of Würzburg; University Hospital of Freiburg; University Hospital Berlin Charite
• Investigators: Principal Investigator: Anne Koy, MD, University Hospital Cologne, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2014
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimated): March 27, 2014

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; dystonia; DBS; dyskinetic cerebral palsy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Brain Damage, Chronic; Hypoxia; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Uni-Koeln-1603