Motor Cortex Stimulation for Parkinson's Disease

NCT00637260 | Completed DMC

• 1 other identifier: 820117
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson's Disease

Keywords

motorcortex stimulation; Parkinson's disease; neuromodulation

Outcome Measures

Primary Outcomes (1)

• UPDRS III

  12 months - end of crossover

Secondary Outcomes (5)

• UPDRS III

  18, 30 and 31 months

• UPDRS

  6,12, 18, 30, 31 months

• Parkinson's disease quality of life scale(PDQL)

  6, 12, 18, 30, 31 months

• Neuropsychological and mood evaluation

  6, 12, 18, 30 months

• Drug therapy

  6, 12, 18, 30, 31 months

Study Arms (2)

A

EXPERIMENTAL

Device: Motor cortex stimulation on.

B

SHAM COMPARATOR

Device: motor cortex stimulation off

Interventions

Motor cortex stimulation on. DEVICE

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.

Also known as: Motor cortex stimulation on

A

motor cortex stimulation off DEVICE

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.

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University, Italy: lead
• Medtronic: collaborator

Study Sites (1)

Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale

Roma, 00168, Italy

Location

Related Publications (3)

• 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.

  PMID: 17691309 BACKGROUND

• Pagni 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.

  PMID: 15986739 BACKGROUND

• Cioni 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.

  PMID: 18083500 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Beatrice Cioni, MD

  Università Cattolica Roma, Italy

  PRINCIPAL INVESTIGATOR

• Mario Meglio, Prof, MD

  Università Cattolica Roma, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

IT (1)