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

NCT01567332 | Terminated

• 1 other identifier: BRD/10/04-P
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation

  Spontaneous walking speed (comfortable) to 10 meters. The gain on the walking speed of 10 meters will be appreciated by an independent evaluator, blinded to randomization. The evaluation will be made on day 1 pre (T0) and post-stimulation (T1) (for 6 hours before and after 1 h), at D8 (T2) and J21 (T3) for 2 sessions (sham and active) .

  3 months

Secondary Outcomes (6)

• Distance covered in 6 min

  3 months

• - Study of the march by AQM (Gait Deviation Index)

  3 months

• - Consequence of lower limb spasticity (Modified Ashworth Scale of the quadriceps and triceps surae)

  3 months

• Analytical and functional recovery of the lower limb (Fugl-Meyer Scale, the FIM score)

  3 months

• Analytical and functional recovery of upper limb (Fugl-Meyer score and French arm test)

  3 months

Study Arms (2)

rTMS active

EXPERIMENTAL

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

rTMS inactive (sham)

PLACEBO COMPARATOR

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Dr Angelique STEFAN

Nantes, 44000, France

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angélique STEFAN, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 30, 2012
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

FR (1)