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Motor Cortex Stimulation for Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637260
First Posted: March 17, 2008
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
bEATRICE CIONI, Catholic University, Italy
  Purpose

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

Condition Intervention
Parkinson's Disease Device: Motor cortex stimulation on. Device: motor cortex stimulation off

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Motor Cortex Stimulation for Parkinson's Disease. A Prospective Double Blind Randomized Study With Cross-over

Resource links provided by NLM:


Further study details as provided by bEATRICE CIONI, Catholic University, Italy:

Primary Outcome Measures:
  • UPDRS III [ Time Frame: 12 months - end of crossover ]

Secondary Outcome Measures:
  • UPDRS III [ Time Frame: 18, 30 and 31 months ]
  • UPDRS [ Time Frame: 6,12, 18, 30, 31 months ]
  • Parkinson's disease quality of life scale(PDQL) [ Time Frame: 6, 12, 18, 30, 31 months ]
  • Neuropsychological and mood evaluation [ Time Frame: 6, 12, 18, 30 months ]
  • Drug therapy [ Time Frame: 6, 12, 18, 30, 31 months ]

Enrollment: 13
Study Start Date: December 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Other Name: Motor cortex stimulation on
Sham Comparator: B 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.

Detailed Description:

20 Parkinsonian patients will be enrolled. After implantation of a bilateral strip electrode (Resume, Medtronic) over the motor cortex, after setting of optimal stimulation parameters, and after implantation of a neurostimulator, Medtronic, the patient will be randomly assigned to group A (Motor cortex stimulation on) or to group B ( sham stimulation) for 6 months. Randomization will be based on the output of a program based on a random number generation function that will output a 0 or 1 with a 50% chance of having a 1.

At the 6 months visit, a cross-over is scheduled: group A will receive sham stimulation and group B will receive stimulation of the motor cortex for the next 6 months. In group A, the stimulation of the motor cortex will be resumed before the end of the 6 month sham stimulation, when the clinical status of the patient will come back to the status quo ante (UPDRS score equal to baseline pre-implant score).

Both the patients and the evaluating neurologists and neuropsychologists will be blind; only the neurosurgeon will know the state of the stimulator (on or off) and the position and parameters of MCS.

At 12 months, all the patients will be programmed as stimulation on and followed up for further 18 months. At 30 months visit, the clinical evaluation will be performed in on stim-on med, on stim-off med conditions; then the stimulator will be switched off for 1 month and the clinical evaluation will be repeated in off stim-off med and off stim-on med conditions.

The primary endpoint will be the UPDRS III at 12 months (end of the cross over), and subsequently at 18 and 30 months. We will compare the clinical results with the precise site of the stimulating electrodes and we will try to correlate the clinical results with the amount of inhibition induced by motor cortex stimulation.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic PD as diagnosed by a neurologist - a movement disorders specialist, according to the Parkinson Disease Brain Bank criteria, with asymmetrical bradykinesia, rigidity, tremor and postural instability (at least 3 from the above)
  2. Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%).
  3. Disease duration > 5 years
  4. Advanced stage of disease:
  5. UPDRS motor score in off condition >/= 40/108
  6. Hoehn & Yahr stage >/= 3
  7. DBS surgery not indicated or expressly refused by the patient
  8. Antiparkinsonian therapy stable for at least one month prior to implant
  9. Capability to give informed consent to surgery and to the study.

Exclusion Criteria:

  1. Severe cognitive impairment or dementia
  2. Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations)
  3. History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy
  4. Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation )
  5. Lack of informed consent
  6. History of drug or alcohol abuse
  7. Poor general conditions increasing surgical risk or severe illness with poor prognosis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637260


Locations
Italy
Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale
Roma, Italy, 00168
Sponsors and Collaborators
Catholic University, Italy
Medtronic
Investigators
Principal Investigator: Beatrice Cioni, MD Università Cattolica Roma, Italy
Study Chair: Mario Meglio, Prof, MD Università Cattolica Roma, Italy
  More Information

Publications:
Responsible Party: bEATRICE CIONI, MD, Catholic University, Italy
ClinicalTrials.gov Identifier: NCT00637260     History of Changes
Other Study ID Numbers: 820117
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by bEATRICE CIONI, Catholic University, Italy:
motorcortex stimulation
Parkinson's disease
neuromodulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases