Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01567332
First received: March 26, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Hemiplegia
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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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) .



Secondary Outcome Measures:
  • Distance covered in 6 min [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • - Study of the march by AQM (Gait Deviation Index) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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


  • - Consequence of lower limb spasticity (Modified Ashworth Scale of the quadriceps and triceps surae) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Analytical and functional recovery of the lower limb (Fugl-Meyer Scale, the FIM score) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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.


  • Analytical and functional recovery of upper limb (Fugl-Meyer score and French arm test) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Patient satisfaction and quality of life on a visual analog scale and the SF 36. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567332

Locations
France
Dr Angelique STEFAN
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Angélique STEFAN, PH CHU de Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01567332     History of Changes
Other Study ID Numbers: 10/04-P
Study First Received: March 26, 2012
Last Updated: January 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hemiplegia
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014