Advertisement

Topics

Motor Cortex Stimulation for Parkinson's Disease

2014-08-27 03:32:07 | BioPortfolio

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

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Conditions

Parkinson's Disease

Intervention

Motor cortex stimulation on., motor cortex stimulation off

Location

Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale
Roma
Italy
00168

Status

Recruiting

Source

Catholic University, Italy

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:07-0400

Clinical Trials [4937 Associated Clinical Trials listed on BioPortfolio]

The Efficacy of Motor Cortex Stimulation for Pain Control

The objective is to determine if motor cortex stimulation works for the following conditions: 1. Deafferentation facial pain, 2. Upper extremity complex regional pain syndrome ...

Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-d...

Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual site-dual ...

Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease

The problems in motor activity associated with Parkinson's disease are still poorly understood. Patients with Parkinson's disease often suffer from extremely slow movements (bradykinesia)...

Role of the Posterior Parietal Cortex in the Processing of Sensory Information

Although the primary motor cortex is considered has the common final pathway of motor commands, it is influenced by several structures as, for example, the premotor cortex and the posterio...

PubMed Articles [20043 Associated PubMed Articles listed on BioPortfolio]

A reappraisal of pain-paired associative stimulation suggesting motor inhibition at spinal level.

Paired associative stimulation (PAS) can modulate motor excitability and consists of delivering repeated pairs of peripheral sensory stimulation combined with transcranial magnetic stimulation (TMS) o...

Patterned low frequency deep brain stimulation induces motor deficits and modulates cortex-basal ganglia neural activity in healthy rats.

Deep brain stimulation (DBS) is an effective therapy for movement disorders including Parkinson's disease (PD), although the mechanisms of action remain unclear. Abnormal oscillatory neural activity i...

Quality of Life After Motor Cortex Stimulation: Clinical Results and Systematic Review of the Literature.

Motor cortex stimulation (MCS) is routinely used for the treatment of chronic neuropathic pain but its effect on quality of life remains uncertain.

Atlas-Independent, Electrophysiological Mapping of the Optimal Locus of Subthalamic Deep Brain Stimulation for the Motor Symptoms of Parkinson Disease.

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) improves motor symptoms of Parkinson disease (PD). However, motor outcomes can be variable, perhaps due to inconsistent positioning of the...

Motor Cortex Stimulation Therapy for Relief of Central Post-Stroke Pain: A Retrospective Study with Neuropathic Pain Symptom Inventory.

Motor cortex stimulation (MCS) has been used in the treatment of chronic neuropathic pain for more than 25 years. However, the mechanisms and outcome predictors still represent major challenges.

Medical and Biotech [MESH] Definitions

A composite area of the cerebral cortex concerned with motor control and sensory perception comprising the motor cortex areas, the somatosensory areas, the gustatory cortex, the olfactory areas, the auditory cortex, and the visual cortex.

The electrical response evoked in a muscle or motor nerve by electrical or magnetic stimulation. Common methods of stimulation are by transcranial electrical and TRANSCRANIAL MAGNETIC STIMULATION. It is often used for monitoring during neurosurgery.

Mild or moderate loss of motor function accompanied by spasticity in the lower extremities. This condition is a manifestation of CENTRAL NERVOUS SYSTEM DISEASES that cause injury to the motor cortex or descending motor pathways.

Area of the frontal lobe concerned with primary motor control. It lies anterior to the central sulcus.

The electric response evoked in the CEREBRAL CORTEX by ACOUSTIC STIMULATION or stimulation of the AUDITORY PATHWAYS.

More From BioPortfolio on "Motor Cortex Stimulation for Parkinson's Disease"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Parkinson's Disease
Parkinson's is a progressive neurological condition, affecting one person in every 500, 95% of which are over 40. It is caused by degeneration of more than 70% of the substantia nigra, which depletes the dopamine (the neurotransmitter involved in pro...


Searches Linking to this Trial