Clinical Trial: Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

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. In total, 20 patients aged 7-18 years diagnosed with dyskinetic cerebral palsy, who will receive DBS, should be included. 11 German DBS-centres will participate in the trial.

We assume that DBS reduces the severity of dystonia and improves the quality of life in these patients.


Detailed Summary:
Sponsor: University Hospital of Cologne

Current Primary Outcome: Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) [ Time Frame: CPCHILD 12 months after DBS ]

Difference in CPCHILD before and 12 months on DBS (response=improvement > 10%)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability [ Time Frame: 0, 6 and 12 months after DBS ]
  • Dyskinesia Impairment Scale [ Time Frame: 0 and 12 months ]
  • Tardieu Scale [ Time Frame: 0 and 12 months after DBS ]
  • Frenchay Dysarthria Assessment [ Time Frame: 0 and 12 months after DBS ]
  • SF-36 [ Time Frame: 0, 6 and 12 months after DBS ]
  • Strengths and Difficulties Questionnaire [ Time Frame: 0, 6 and 12 months after DBS ]
  • Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R) [ Time Frame: 0 and 12 months ]
  • Attentional Network Test (ANT) [ Time Frame: 0 and 12 months after DBS ]
  • Non-Verbal-Learning Test (NVLT) [ Time Frame: 0 and 12 months after DBS ]
  • Wong Baker Faces [ Time Frame: 0, 6 and 12 months after DBS ]
  • Family Scale (FaBel) [ Time Frame: 0, 6 and 12 months ]
  • CPCHILD [ Time Frame: 0 and 6 months after DBS ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: COPM 0 and 12 months after DBS ]
  • Gross Motor Function Measure (GMFM-66) [ Time Frame: GMFM-66 0 and 12 months after DBS ]
  • Gross Motor Function Classification System (GMFCS) [ Time Frame: GMFCS 0 and 12 months after DBS ]


Original Secondary Outcome: Same as current

Information By: University Hospital of Cologne

Dates:
Date Received: March 24, 2014
Date Started: February 2014
Date Completion:
Last Updated: March 24, 2014
Last Verified: March 2014