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Motor Cortex Stimulation for Parkinson's Disease

NCT00637260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-09-02

No results posted yet for this study

Summary

Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent Therefore, other approaches should be considered.We identified the motor cortex as a possible candidate and therefore we propose a double-blind randomized prospective study in 20 Parkinson patients in order:

* to test the efficacy of epidural motor cortex stimulation in Parkinson disease (primary endpoint: UPDRS III at 12 months at the end of the cross-over)
* to find out optimal electrode position and optimal stimulation parameters

Conditions

Interventions

DEVICE

Motor cortex stimulation on.

The parameters of stimulation will be: contact 0 cathode, contact 3anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5Volts. The stimulator will be switched on, continuously.

DEVICE

motor cortex stimulation off

The parameters of stimulation will be: contact 0 cathode, contact 3 anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5 volts. The stimulator will be switched off.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Catholic University, Italy

    lead OTHER

Principal Investigators

  • Beatrice Cioni, MD · Università Cattolica Roma, Italy

  • Mario Meglio, Prof, MD · Università Cattolica Roma, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637260 on ClinicalTrials.gov