NCT01567332

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemiplegia

Interventions

Type	Name	Description
DEVICE	SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coil	For each patient, stimulation inactive (sham) and 1 Hz stimulation activates the healthy motor cortex (randomization). Active or sham session: Each session includes a series of 5 sessions of 20 'weekly (daily for 5 d) evaluation and pre-rTMS (T0 within 6 h before the procedure) and 1h post-rTMS (T1), at J8 (T2) and J21 (T3). 6-week interval between two sessions.
DEVICE	SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coil	For each patient, stimulation inactive (sham) and 1 Hz stimulation activates the healthy motor cortex (randomization). Active or sham session: Each session includes a series of 5 sessions of 20 'weekly (daily for 5 d) evaluation and pre-rTMS (T0 within 6 h before the procedure) and 1h post-rTMS (T1), at J8 (T2) and J21 (T3). 6-week interval between two sessions.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-03-30
• Last updated: 2016-08-08

Locations

1 site across 1 country: France