StrokePhase 1NCT01333579
Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
A Phase 1 study testing Repetitive transcranial magnetic stimulation in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere (UH) transiently improves motor function in patients in the chronic phase after stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Dec 2012
- Phase
- Phase 1
- 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
- First-ever ischemic stroke in the internal carotid artery territory confirmed by CT or MRI, 5-45 days before, leading to contralateral hand weakness
- Age, 18-80 years
Who cannot join
- Cardiac pacemaker
- Pregnancy
- Implantable medication pump
- Intracranial hypertension
- History of seizures
- Metal in the head
Show all 12Show fewer
- Decompressive surgery
- Other neurological diseases
- Shoulder pain
- Joint deformity in the paretic upper limb
- Severe chronic disease such as end-stage cancer or end-stage renal failure
- Inability to provide informed consent due to severe language or cognitive impairment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Neuroestimulação, HC/FMUSP
São Paulo, São Paulo, 05403000
About this study
Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere (UH) transiently improves motor function in patients in the chronic phase after stroke. The goal of this study is to investigate effects on motor recovery of low-frequency rTMS of the UH, administered in the subacute phase after stroke.
Read the detailed description
Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after stroke. Even mild impairments of the upper limb negatively impact disability and quality of life in these patients significantly contributes to disability. Therapeutic alternatives for hand motor rehabilitation are deeply needed.
Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the paretic hand Both strategies, as well as the combination of both, have yielded encouraging results when applied in proof-of-principle, single-session studies to patients with mild hand motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies included patients less than six months after stroke, and effects of LF-rTMS of the unaffected hemisphere in patients with severe motor impairment in the subacute phase have not been yet reported.
The investigators opted for a novel approach to enhance hand motor recovery, by examining feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor deficits, will have minimal adverse events and will enhance effects of customary rehabilitation on hand motor performance.
- Conditions
- Stroke
- Being tested
- Repetitive transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationOther
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | 1Hz active rTMS delivered to the unaffected hemisphere Receives: Other: Repetitive transcranial magnetic stimulation |
| Placebo rTMS | Placebo comparator | 1Hz placebo rTMS delivered to the vertex Receives: Other: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function of the paretic hand evaluated with the Jebsen-Taylor test
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of patients able to comply with the protocol
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Secondary outcomes (6)
Force of the paretic hand
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Fugl-Meyer evaluation of motor performance (upper limb)
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Disability evaluated with the modified Rankin scale
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Functional Independence Measure
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Neurological impairment evaluated with the NIH Stroke Scale
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Measures of corticomotor excitability evaluated with transcranial magnetic stimulation
Measured: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startFeb 2008
- Primary completionJul 2012
- Study completionDec 2012
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.
- More trials run by University of Sao Paulo General 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Adriana Bastos Conforto, University of Sao Paulo General Hospital
- Investigators
- Adriana Conforto, MD, PhD, Principal investigator, HC/FMUSP/Fundação Faculdade de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333579
- Sponsor's protocol ID
- NCT2006/55504-0
- Status last verified
- Sep 2013
- First submitted
- 4 Apr 2011
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Anjos SM, Cohen LG, Sterr A, de Andrade KN, Conforto AB. Translational neurorehabilitation research in the third world: what barriers to trial participation can teach us. Stroke. 2014 May;45(5):1495-7. doi: 10.1161/STROKEAHA.113.003572. Epub 2014 Mar 18.
PubMed 24643406
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
- ClinicalTrials.gov ID
- NCT01333579
- Acronym / sponsor ID
- NCT2006/55504-0
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2011 (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.
Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere (UH) transiently improves motor function in patients in the chronic phase after stroke. The goal of this study is to investigate effects on motor recovery of low-frequency rTMS of the UH, administered in the subacute phase after stroke.
Detailed description
Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after stroke. Even mild impairments of the upper limb negatively impact disability and quality of life in these patients significantly contributes to disability. Therapeutic alternatives for hand motor rehabilitation are deeply needed.
Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the paretic hand Both strategies, as well as the combination of both, have yielded encouraging results when applied in proof-of-principle, single-session studies to patients with mild hand motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies included patients less than six months after stroke, and effects of LF-rTMS of the unaffected hemisphere in patients with severe motor impairment in the subacute phase have not been yet reported.
The investigators opted for a novel approach to enhance hand motor recovery, by examining feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor deficits, will have minimal adverse events and will enhance effects of customary rehabilitation on hand motor performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Other: Repetitive transcranial magnetic stimulation1Hz active rTMS delivered to the unaffected hemisphere |
| Placebo rTMS | Placebo comparator | Other: Repetitive transcranial magnetic stimulation1Hz placebo rTMS delivered to the vertex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First-ever ischemic stroke in the internal carotid artery territory confirmed by CT or MRI, 5-45 days before, leading to contralateral hand weakness
- Age, 18-80 years
Key exclusion criteria (12 listed)
- Cardiac pacemaker
- Pregnancy
- Implantable medication pump
- Intracranial hypertension
- History of seizures
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 stimulationRepetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days. | Other | Active rTMS, Placebo rTMS |
Primary outcome
Motor function of the paretic hand evaluated with the Jebsen-Taylor test
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of patients able to comply with the protocol
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
6 secondary outcomes
Force of the paretic hand
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Fugl-Meyer evaluation of motor performance (upper limb)
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Disability evaluated with the modified Rankin scale
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Functional Independence Measure
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Neurological impairment evaluated with the NIH Stroke Scale
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Measures of corticomotor excitability evaluated with transcranial magnetic stimulation
Time frame: Baseline, two weeks, 1 month, 3 and six months after end of 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 17 Sep 2013.
- Derived from this study: PubMed 24643406Anjos SM, Cohen LG, Sterr A, de Andrade KN, Conforto AB. Translational neurorehabilitation research in the third world: what barriers to trial participation can teach us. Stroke. 2014 May;45(5):1495-7. doi: 10.1161/STROKEAHA.113.003572. Epub 2014 Mar 18.
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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.
Adriana Conforto, MD, PhD principal investigator
HC/FMUSP/Fundação Faculdade de Medicina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repetitive transcranial magnetic stimulation in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 12 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 17 Sep 2013. 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 Brazil. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Motor function of the paretic hand evaluated with the Jebsen-Taylor test (time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment). The study lists 3 primary outcomes in all. 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 NCT01333579, 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 17 Sep 2013.