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

NCT ID: NCT01567332

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

rTMS active

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

rTMS inactive (sham)

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angélique STEFAN, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Dr Angelique STEFAN

Nantes, , France

Countries

France

Other Identifiers

BRD/10/04-P

Identifier Type: -

Identifier Source: org_study_id