Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Hemiplegia

Treatments: Device: SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coil; Device: SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coil

Study type: Interventional

Funder types: Other

Identifiers

NCT01567332

BRD/10/04-P

Details and patient eligibility

About

Recovery of neurological deficits after stroke results from a reorganization of cortical activities, possibly through brain plasticity. Repetitive Transcranial Magnetic Stimulation (rTMS-MagproR30) produces changes in cortical excitability, generates phenomena of neuroplasticity. Its use to improve function after stroke, particularly of the upper limb, was validated. The investigators propose to evaluate in a prospective pilot against placebo, the benefit of rTMS at low frequency (1Hz) on the unaffected hemisphere in the short and medium term, especially on walking function and spasticity in patients with sequelae of cerebral infarction in the MCA territory with gait disturbance and motor weakness of the upper limb.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years of two sexes
• Cerebral infarction older than 12 months
• NIH score > 4
• Patient able to walk with or without technical assistance, Rankin score greater than or equal to 3
• No changes can interfere with treatment of spasticity in the 3 months preceding the study (benzodiazepines, baclofen, dantrolene, botulinum toxin ...)
• No history of generalized epilepsy unbalanced
• Free and informed consent signed by the patient
• MRI with ancient anatomical sequence confirming the accident sylvian

Exclusion criteria

• Stroke with motor sequelae of cerebral infarction prior to qualifying
• Alteration of the course prior to stroke
• Generalized epilepsy unbalanced
• Arrhythmias untreated
• Injection of botulinum toxin in the previous 4 months of randomization and 2 months after randomization
• Severe aphasia or cognitive impairment that interferes with the understanding of the tasks
• Presence of ferromagnetic material intracranial
• Pacemaker

Trial design

10 participants in 2 patient groups, including a placebo group

rTMS active

Experimental group

Treatment:

Device: SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coil

rTMS inactive (sham)

Placebo Comparator group

Treatment:

Device: SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coil