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 [3919 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 ...

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)...

Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients

The purpose of this study is to identify and establish how the area of the brain that controls motor function (motor cortex) might serve as a new focus for treatment for stroke. The therap...

Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease

The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the p...

Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery

The experience of pain derives from changes in brain excitability. Therefore, modulating the excitability of cortical areas involved in pain processing may become an attractive option in t...

PubMed Articles [19361 Associated PubMed Articles listed on BioPortfolio]

Cortico-cerebellar Networks Drive Sensorimotor Learning in Speech.

The motor cortex and cerebellum are thought to be critical for learning and maintaining motor behaviors. Here we use transcranial direct current stimulation (tDCS) to test the role of the motor cortex...

The optimal stimulation site for high-frequency repetitive transcranial magnetic stimulation in Parkinson's disease: A double-blind crossover pilot study.

Many reports have shown improvements in motor symptoms after repetitive transcranial magnetic stimulation (rTMS). However, the best stimulation area in the brain has not currently been determined. We ...

Comparison of Electrical and Ultrasound Neurostimulation in Rat Motor Cortex.

Ultrasound (US) is known to non-invasively stimulate and modulate brain function; however, the mechanism of action is poorly understood. This study tested US stimulation of rat motor cortex (100 W/cm(...

Modulation of motor cortex excitability by paired peripheral and transcranial magnetic stimulation.

Repetitive application of peripheral electrical stimuli paired with transcranial magnetic stimulation (rTMS) of M1 cortex at low frequency, known as paired associative stimulation (PAS), is an effecti...

Optogenetic stimulation of cortex to map evoked whisker movements in awake head-restrained mice.

Whisker movements are used by rodents to touch objects in order to extract spatial and textural tactile information about their immediate surroundings. To understand the mechanisms of such active sens...

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"

Quick Search
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