HemiplegiarTMSNCT01567332
Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia
A study of Hemiplegia, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiplegia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemiplegia
- Being tested
- SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coil, SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coil
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coilDevice
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.
SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coilDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| rTMS active | Experimental | Not described Receives: Device: SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coil |
| rTMS inactive (sham) | Placebo comparator | Not described Receives: Device: SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 3 months
Secondary outcomes (6)
Distance covered in 6 min
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angélique STEFAN, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567332
- Sponsor's protocol ID
- BRD/10/04-P
- Acronym
- rTMS
- Status last verified
- Aug 2016
- First submitted
- 26 Mar 2012
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Walking After Repetitive Transcranial Magnetic Stimulation (rTMS) Inhibitory 1Hz in Vascular Hemiplegia.
- ClinicalTrials.gov ID
- NCT01567332
- Acronym / sponsor ID
- rTMS / BRD/10/04-P
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ...)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coilFor 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 | rTMS active |
| SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coilFor 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 | rTMS inactive (sham) |
Primary outcome
Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation
Time frame: 3 months
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) .
6 secondary outcomes
Distance covered in 6 min
Time frame: 3 months
- Study of the march by AQM (Gait Deviation Index)
Time frame: 3 months
- Consequence of lower limb spasticity (Modified Ashworth Scale of the quadriceps and triceps surae)
Time frame: 3 months
Analytical and functional recovery of the lower limb (Fugl-Meyer Scale, the FIM score)
Time frame: 3 months
Analytical and functional recovery of upper limb (Fugl-Meyer score and French arm test)
Time frame: 3 months
Patient satisfaction and quality of life on a visual analog scale and the SF 36.
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angélique STEFAN, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hemiplegia, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous walking speed of 10 meters. The evaluation of the primary endpoint is blind to the stimulation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.