Influence of deep brain stimulation in the pedunculopontine nuclei on therapy-resistant gait and balance disorders in patients with idiopathic and atypical parkinsonian syndromes

Not Applicable

• Conditions: G20.9; G23.1; Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]

• Registration Number: DRKS00012596
• Lead Sponsor: niversitätsklinik für Stereotaktische Neurochirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-11-12
• Study Start: 2017-11-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Diagnosis of a probable PSP (Parkinsonsyndrom, progressive disease after the age of 40, PSP and marked postural instability with falls after the first year of the disease)
- UPDRS- item 13> / = 2 (2 = occasional falls, less than once a day)
or
PSPRS- item 5> / = 2 (average frequency of falls when walking without support, 2 = 1-4 falls per month)
- UPDRS- item 30> / = 2 (posture stability, 2 = response to a sudden backward-Pulling on the shoulders, while the patient stands with open eyes and legs slightly apart. The patient is prepared for it: no compensatory movement, would fall if not caught by the examiner)
or
PSPRS- Item 27> / = 2 (postural stability, patient would fall if not caught by the examiner)

Exclusion Criteria

- Dementia (Mattis Dementia Rating Scale Score <130/144)
- pronounced cerebral atrophy or pronounced brain parenchyma damage
- coagulation disorders (eg oral anticoagulation therapy, hepatic dysfunction)
- Reduced immune defense (immunosuppressive therapy or immune disease)
- other internal concomitant disease with significantly increased risk of operation
- Malignant disease
- Known epilepsy
- severe psychiatric illness (psychosis, severe depression, severe personality disorder).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the effectiveness of DBS (Deep Brain Stimulation) in the area of the PPN (pedunculopotines nuclei) in patients with the diagnosis of PSP (Progressive Supranuclear Palsy) on the basis of clinical and apparative changes of the motor scales by the THS in the PPN in the long-term course up to 24 months

Secondary Outcome Measures

Name	Time	Method
- Evaluation of optimal target point determination for implantation of electrodes for DBS (Deep Brain Stimulation) into the PPN (pedunculopotines nuclei) <br>- Evaluation of the safety and tolerability of the implantation of electrodes for deep brain stimulation into the PP