StrokeNCT03456362
Cerebellar rTMS to Improve Gait Recovery
A study testing REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION in people with Stroke and Gait, Hemiplegic, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2014to 1 Oct 2017
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever-chronic ischemic stroke, i.e. at least 6 months after the stroke event,
- Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS <15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners)
- No contraindication to brain MRI
- MEP recordable in order to evaluate the resting motor threshold (RMT)
Who cannot join
- Epilepsy
- Severe general impairment or concomitant diseases (tumors, etc.)
- Age> 80 years
- Infections in progress
- Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
- Treatment with benzodiazepines, baclofen, antidepressants, clonidine, beta blockers and other potentially interfering drug treatments on plasticity phenomena.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIONDevice
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
| Study group | Role | What they receive |
|---|---|---|
| Cerebellar iTBS | Active comparator | Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. Receives: Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION |
| Sham iTBS | Sham comparator | Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. Receives: Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS) for gait and balance
Assessment of gait and balance functions
Measured: Change from baseline at the end of three weeks treatment
Secondary outcomes (4)
Fugl-Meyer Assessment (FMA) scale
Assessment of motor functions
Measured: Change from baseline at the end of three weeks treatment
Barthel Index (BI)
Assessment of functional abilities
Measured: Change from baseline at the end of three weeks treatment
Neurophysiological assessment of cortical activity
evaluation of cortical activity by means of TMS in combination with EEG
Measured: Change from baseline at the end of three weeks treatment
Gait analysis
evaluation of locomotion
Measured: Change from baseline at the end of three weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Mar 2014
- Primary completion1 Jun 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Koch, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456362
- Sponsor's protocol ID
- RF-2011-02349953
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
PubMed 30476999
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
- ClinicalTrials.gov ID
- NCT03456362
- Acronym / sponsor ID
- RF-2011-02349953
- Conditions
- Stroke, Gait, Hemiplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 7 Mar 2018 (actual)
- 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.
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebellar iTBS | Active comparator | Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIONIntermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. |
| Sham iTBS | Sham comparator | Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIONSham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First ever-chronic ischemic stroke, i.e. at least 6 months after the stroke event,
- Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS <15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners)
- No contraindication to brain MRI
- MEP recordable in order to evaluate the resting motor threshold (RMT)
Key exclusion criteria (6 listed)
- Epilepsy
- Severe general impairment or concomitant diseases (tumors, etc.)
- Age> 80 years
- Infections in progress
- Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
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 |
|---|---|---|
| REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIONtheta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability | Device | Cerebellar iTBS, Sham iTBS |
Primary outcome
Berg Balance Scale (BBS) for gait and balance
Time frame: Change from baseline at the end of three weeks treatment
Assessment of gait and balance functions
4 secondary outcomes
Fugl-Meyer Assessment (FMA) scale
Time frame: Change from baseline at the end of three weeks treatment
Barthel Index (BI)
Time frame: Change from baseline at the end of three weeks treatment
Neurophysiological assessment of cortical activity
Time frame: Change from baseline at the end of three weeks treatment
Gait analysis
Time frame: Change from baseline at the end of three weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 30476999Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION in people with Stroke and Gait, Hemiplegic, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 7 Mar 2018. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Berg Balance Scale (BBS) for gait and balance (time frame: Change from baseline at the end of three weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456362, which also lists 1 linked publication.
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 7 Mar 2018.