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Motor Cortex Stimulation for Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Catholic University, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Catholic University, Italy
ClinicalTrials.gov Identifier:
NCT00637260
First received: March 10, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Catholic University, Italy:

Primary Outcome Measures:
  • UPDRS III [ Time Frame: 12 months - end of crossover ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UPDRS III [ Time Frame: 18, 30 and 31 months ] [ Designated as safety issue: No ]
  • UPDRS [ Time Frame: 6,12, 18, 30, 31 months ] [ Designated as safety issue: No ]
  • Parkinson's disease quality of life scale(PDQL) [ Time Frame: 6, 12, 18, 30, 31 months ] [ Designated as safety issue: No ]
  • Neuropsychological and mood evaluation [ Time Frame: 6, 12, 18, 30 months ] [ Designated as safety issue: Yes ]
  • Drug therapy [ Time Frame: 6, 12, 18, 30, 31 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: June 2010 (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.
Other Name: Motor cortex stimulation 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637260

Contacts
Contact: Annarita Bentivoglio, MD +390630151 annarita.bentivoglio@rm.unicatt.it

Locations
Italy
Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale Recruiting
Roma, Italy, 00168
Contact: Beatrice Cioni, MD     +39063015 ext 5468     bcioni@rm.unicatt.it    
Principal Investigator: Beatrice Cioni, MD            
Sub-Investigator: Annarita Beantivoglio, MD            
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: Cioni Beatrice, MD, Catholic University
ClinicalTrials.gov Identifier: NCT00637260     History of Changes
Other Study ID Numbers: 820117
Study First Received: March 10, 2008
Last Updated: January 27, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013