Parkinson's DiseaseNCT00637260
Motor Cortex Stimulation for Parkinson's Disease
A study testing Motor cortex stimulation on. and motor cortex stimulation off in people with Parkinson's Disease, run by Catholic University, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Motor cortex stimulation on. and motor cortex stimulation off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%).
- Disease duration > 5 years
- Advanced stage of disease:
- UPDRS motor score in off condition >/= 40/108
- Hoehn \& Yahr stage >/= 3
Show all 9Show fewer
- DBS surgery not indicated or expressly refused by the patient
- Antiparkinsonian therapy stable for at least one month prior to implant
- Capability to give informed consent to surgery and to the study.
Who cannot join
- Severe cognitive impairment or dementia
- Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations)
- History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy
- Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation )
- Lack of informed consent
- History of drug or alcohol abuse
- Poor general conditions increasing surgical risk or severe illness with poor prognosis.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale
Roma, 00168
About this study
Official title: Motor Cortex Stimulation for Parkinson's Disease. A Prospective Double Blind Randomized Study With Cross-over
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
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Motor cortex stimulation on., motor cortex stimulation off
- Keywords
- motorcortex stimulation, Parkinson's disease, neuromodulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor cortex stimulation on.Device
Also called 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.
motor cortex stimulation offDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Motor cortex stimulation on. |
| B | Sham comparator | Not described Receives: Device: motor cortex stimulation off |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS III
Measured: 12 months - end of crossover
Secondary outcomes (5)
UPDRS III
Measured: 18, 30 and 31 months
UPDRS
Measured: 6,12, 18, 30, 31 months
Parkinson's disease quality of life scale(PDQL)
Measured: 6, 12, 18, 30, 31 months
Neuropsychological and mood evaluation
Measured: 6, 12, 18, 30 months
Drug therapy
Measured: 6, 12, 18, 30, 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, bEATRICE CIONI, Catholic University, Italy
- Investigators
- Beatrice Cioni, MD, Principal investigator, Università Cattolica Roma, ItalyMario Meglio, Prof, MD, Study chair, Università Cattolica Roma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637260
- Sponsor's protocol ID
- 820117
- Status last verified
- Sep 2015
- First submitted
- 10 Mar 2008
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cioni B. Motor cortex stimulation for Parkinson's disease. Acta Neurochir Suppl. 2007;97(Pt 2):233-8. doi: 10.1007/978-3-211-33081-4_26.
PubMed 17691309Pagni CA, Altibrandi MG, Bentivoglio A, Caruso G, Cioni B, Fiorella C, Insola A, Lavano A, Maina R, Mazzone P, Signorelli CD, Sturiale C, Valzania F, Zeme S, Zenga F. Extradural motor cortex stimulation (EMCS) for Parkinson's disease. History and first results by the study group of the Italian neurosurgical society. Acta Neurochir Suppl. 2005;93:113-9. doi: 10.1007/3-211-27577-0_19.
PubMed 15986739Cioni B, Meglio M, Perotti V, De Bonis P, Montano N. Neurophysiological aspects of chronic motor cortex stimulation. Neurophysiol Clin. 2007 Dec;37(6):441-7. doi: 10.1016/j.neucli.2007.10.007. Epub 2007 Nov 1.
PubMed 18083500
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Cortex Stimulation for Parkinson's Disease. A Prospective Double Blind Randomized Study With Cross-over
- ClinicalTrials.gov ID
- NCT00637260
- Acronym / sponsor ID
- 820117
- Conditions
- Parkinson's Disease
- Keywords
- motorcortex stimulation, Parkinson's disease, neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Catholic University, ItalyUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Motor cortex stimulation on. |
| B | Sham comparator | Device: motor cortex stimulation off |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%).
- Disease duration > 5 years
- Advanced stage of disease:
- UPDRS motor score in off condition >/= 40/108
Key exclusion criteria (7 listed)
- Severe cognitive impairment or dementia
- Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations)
- History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy
- Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation )
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor cortex stimulation on.Also: Motor cortex stimulation onThe 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 | A |
| motor cortex stimulation offThe 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. | Device | B |
Primary outcome
UPDRS III
Time frame: 12 months - end of crossover
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Background: PubMed 17691309Cioni B. Motor cortex stimulation for Parkinson's disease. Acta Neurochir Suppl. 2007;97(Pt 2):233-8. doi: 10.1007/978-3-211-33081-4_26.
- Background: PubMed 15986739Pagni CA, Altibrandi MG, Bentivoglio A, Caruso G, Cioni B, Fiorella C, Insola A, Lavano A, Maina R, Mazzone P, Signorelli CD, Sturiale C, Valzania F, Zeme S, Zenga F. Extradural motor cortex stimulation (EMCS) for Parkinson's disease. History and first results by the study group of the Italian neurosurgical society. Acta Neurochir Suppl. 2005;93:113-9. doi: 10.1007/3-211-27577-0_19.
- Background: PubMed 18083500Cioni B, Meglio M, Perotti V, De Bonis P, Montano N. Neurophysiological aspects of chronic motor cortex stimulation. Neurophysiol Clin. 2007 Dec;37(6):441-7. doi: 10.1016/j.neucli.2007.10.007. Epub 2007 Nov 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Cioni, MD principal investigator
Università Cattolica Roma, Italy
Mario Meglio, Prof, MD study chair
Università Cattolica Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor cortex stimulation on. and motor cortex stimulation off in people with Parkinson's Disease, run by Catholic University, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS III (time frame: 12 months - end of crossover). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637260, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.