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Dyskinetic Cerebral Palsy Due to Perinatal HypoxiaSTIM-CPNCT02097693

Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy

An observational study of Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia, run by University Hospital of Cologne at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 18 years
How many people
16 participants
Where
1 siteGermany
Study dates
4 Mar 2014to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: primary care clinic

Who may be able to join

  • 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
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  • 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

Who cannot join

  • • 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.)
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Cologne

    Cologne, Northern Westfalia, 50935

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
DBS, quality of life, dystonia, dyskinetic cerebral palsy
Medical subject headings
Dystonia, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02097693
Study groupRoleWhat they receive
dyston-dyskinetic cerebral palsyYoung patients with dyston-dyskinetic cerebral palsy who receive DBS in the GPi

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: CPCHILD 12 months after DBS

Secondary outcomes (15)

  1. Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability

    Assessment of the severity of dystonia

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

  2. Dyskinesia Impairment Scale

    Assessment of the severity of chorea and dystonia

    Measured: 0, 12, 24 and 36 months

  3. Tardieu Scale

    Assessment of the severity of spasticity

    Measured: 0 and 12 months after DBS

  4. Frenchay Dysarthria Assessment

    Assessment of speech and swallowing

    Measured: 0, 12, 24 and 36 months after DBS

  5. SF-36

    Assessment of Quality of life

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

  6. Strengths and Difficulties Questionnaire

    Assessment of mood and attention

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

  7. Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R)

    Assessment of Cognition

    Measured: 0 and 12 months

  8. Attentional Network Test (ANT)

    Assessment of Attention

    Measured: 0 and 12 months after DBS

  9. Non-Verbal-Learning Test (NVLT)

    Assessment of cognition

    Measured: 0 and 12 months after DBS

  10. Wong Baker Faces

    Assessment of pain

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

  11. Family Scale (FaBel)

    Assessment of the burden for caregivers

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

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

    Assessment of quality of life

    Measured: 0, 6, 24 and 36 months after DBS

  13. Canadian Occupational Performance Measure (COPM)

    Assessment of activities of daily living

    Measured: COPM 0 and 12 months after DBS

  14. Gross Motor Function Measure (GMFM-66)

    Assessment of physical disability

    Measured: GMFM-66 0 and 12 months after DBS

  15. Gross Motor Function Classification System (GMFCS)

    Degree of physical impairment

    Measured: GMFCS 0, 12, 24 and 36 months after DBS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2014 (estimated)
  2. Study start4 Mar 2014
  3. Primary completion10 Mar 2020
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02097693
Sponsor's protocol ID
Uni-Koeln-1603
Acronym
STIM-CP
Status last verified
Mar 2025
First submitted
24 Mar 2014
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 34967053

Questions about this trial

What is this clinical trial studying?

An observational study of Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia, run by University Hospital of Cologne at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) (time frame: CPCHILD 12 months after DBS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02097693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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