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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hemiplegia
• Intervention / Treatment: 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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Dr Angelique STEFAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS active	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.
Placebo Comparator: rTMS inactive (sham)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance covered in 6 min		3 months
- Study of the march by AQM (Gait Deviation Index)	Measurement parameters spatiotemporal, kinematic and kinetic walking on day 1 pre-test, J8, J21 of the two phases. This measurement is performed using 4 cameras and markers installed in the room where runs quantified analysis of the march. Patients are fitted with reflective markers so that their movements are recorded and then digitized	3 months
- Consequence of lower limb spasticity (Modified Ashworth Scale of the quadriceps and triceps surae)	Used to describe a subjective rate of increase in resistance or tone perceived by an examiner when a member engages in the mobility sector. Coast of the score 0-4 (0 no strength, no mobility possible, 4). The scale is used to measure the first tone. Its reproducibility is quite low but it is the scale used and accepted. It is brief and feasible (no equipment, but requires training).Will be measured pre and post test J1, J8 and J21 of the two phases.	3 months
Analytical and functional recovery of the lower limb (Fugl-Meyer Scale, the FIM score)	The scale sensorimotor Fugl-Meyer: widely used in the literature, gold standard. The evolution motor is well defined. First part to obtain three subscores: MS (33 items, side 0 to 66), MI (17 items sides from 0 to 34), equilibrium (7 items sides from 0 to 14). The score can be used in total or subgroup. It requires 30 to 45 minutes with a trained evaluator. It can easily be used in clinical practice. A change in score <10 may be due to simple measurement error and may not reflect a significant change in motor skills. Will be measured pre and post test J1, J8 and J21 of the two phases.	3 months
Analytical and functional recovery of upper limb (Fugl-Meyer score and French arm test)	The Frenchay Arm Test: This test, rapid (5 min) includes five tasks rated 0 or 1, requiring the use of one or both hands: draw a line, then install a lift cylinder, lift and then rest a glass of water, remove and replace a clothespin and combing. The score ranges from 0 to 5. The FAT is used to evaluate both the proximal motor skills, manual dexterity and bimanual coordination. It is validated in hemiplegic, reproduced over time and between observers, but its ceiling and floor effects are very important. Will be measured pre and post test J1, J8 and J21 of the two phases.	3 months
Patient satisfaction and quality of life on a visual analog scale and the SF 36.	Is a generic health scale created to measure health status in the general population. It includes 36 items organized into eight dimensions, physical functioning, physical limitations, pain, social functioning, mental health, emotion, vitality, general health perceptions. It includes two questions to estimate the change of health status on the past four weeks. The test is validated, it is a simple questionnaire and short of 10 minutes (acceptability).It requires no training to administer. It can be done by mail (Feasibility).She will be provided on D8 of the two phases.	3 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Angélique STEFAN, PH, CHU de Nantes

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: BRD/10/04-P