Clinical trial NCT01567332: Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia
Official title: Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation
timeFrame: 3 months
Secondary outcomes:
measure: Distance covered in 6 min
timeFrame: 3 months
measure: - Study of the march by AQM (Gait Deviation Index)
timeFrame: 3 months
measure: - Consequence of lower limb spasticity (Modified Ashworth Scale of the quadriceps and triceps surae)
timeFrame: 3 months
measure: Analytical and functional recovery of the lower limb (Fugl-Meyer Scale, the FIM score)
timeFrame: 3 months
measure: Analytical and functional recovery of upper limb (Fugl-Meyer score and French arm test)
timeFrame: 3 months
measure: Patient satisfaction and quality of life on a visual analog scale and the SF 36.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Dr Angelique STEFAN
Study officials:
affiliation: Nantes University Hospital
name: Angélique STEFAN, PH
role: PRINCIPAL_INVESTIGATOR
References: