Motor Cortex Stimulation for Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00637260|
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : September 2, 2015
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 or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Motor cortex stimulation on. Device: motor cortex stimulation off||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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.
- UPDRS III [ Time Frame: 12 months - end of crossover ]
- 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 ]
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
|Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale|
|Roma, Italy, 00168|
|Principal Investigator:||Beatrice Cioni, MD||Università Cattolica Roma, Italy|
|Study Chair:||Mario Meglio, Prof, MD||Università Cattolica Roma, Italy|