StrokeNEUROSTIMNCT02455427
Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
A study testing Active tDCS and Physical Therapy in people with Stroke, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Active tDCS and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to 31 Mar 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Who cannot join
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- Contraindication for physical therapy.
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- Pregnancy.
- Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- Comprehension aphasia
- Dementia
- Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
Read the detailed description
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
- Conditions
- Stroke
- Being tested
- Active tDCS, Physical Therapy, Sham tDCS
- Keywords
- transcranial direct current stimulation, conventional physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical TherapyOther
Physical therapy will be administered for 60 minutes
Sham tDCSDevice
In sham tDCS, no current will be delivered through the tDCS device.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS+ Physical Therapy | Active comparator | Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) Receives: Device: Active tDCS; Other: Physical Therapy |
| Sham tDCS+Physical Therapy | Sham comparator | Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks) Receives: Other: Physical Therapy; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the intervention as assessed by frequency of adverse events
frequency of adverse events in the active and sham arms
Measured: 2 weeks
Secondary outcomes (12)
Improvement post treatment as measured by the Modified Rankin Scale
Improvement post treatment
Measured: 2 weeks and 14 weeks
Improvement post treatment as measured by the NIH Stroke Scale
Improvement post treatment
Measured: 2 weeks and 14 weeks
Improvement post treatment as measured by the Stroke Impact Scale
Improvement post treatment
Measured: 2 weeks and 14 weeks
Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
Improvement post treatment
Measured: 2 weeks and 14 weeks
Improvement post treatment as measured by the Modified Ashworth Scale
Improvement post treatment
Measured: 2 weeks and 14 weeks
Improvement post treatment as measured by the Motor Activity Log
Improvement post treatment
Measured: 2 weeks and 14 weeks
Montreal Cognitive Assessment Test
No cognitive deterioration post treatment
Measured: 2 weeks and 14 weeks
Structural Connectivity as measured by diffusion tensor imaging analysis
Improvement post treatment
Measured: 2 weeks
Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Improvement post treatment
Measured: 2 weeks
Improvement post treatment as measured by the Barthel index
Improvement post treatment
Measured: 2 week and 14 weeks
Safety of the intervention as assessed by frequency of adverse events
frequency of adverse events in the active and sham arms
Measured: 14 weeks
Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Improvement post treatment
Measured: 2 week and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana B Conforto, MD Phd, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455427
- Sponsor's protocol ID
- 225014
- Acronym
- NEUROSTIM
- Status last verified
- Sep 2018
- First submitted
- 24 Apr 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Deidentified imaging data will be shared with collaborators
Publications
Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024.
PubMed 38922218Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
- ClinicalTrials.gov ID
- NCT02455427
- Acronym / sponsor ID
- NEUROSTIM / 225014
- Conditions
- Stroke
- Keywords
- transcranial direct current stimulation, conventional physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 May 2015 (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.
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
Detailed description
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
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 tDCS+ Physical Therapy | Active comparator | Device: Active tDCS, Other: Physical TherapyActive tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
| Sham tDCS+Physical Therapy | Sham comparator | Other: Physical Therapy, Device: Sham tDCSSham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Key exclusion criteria (11 listed)
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
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 |
|---|---|---|
| Active tDCSActive tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA). | Device | Active tDCS+ Physical Therapy |
| Physical TherapyPhysical therapy will be administered for 60 minutes | Other | Active tDCS+ Physical Therapy, Sham tDCS+Physical Therapy |
| Sham tDCSIn sham tDCS, no current will be delivered through the tDCS device. | Device | Sham tDCS+Physical Therapy |
Primary outcome
Safety of the intervention as assessed by frequency of adverse events
Time frame: 2 weeks
frequency of adverse events in the active and sham arms
12 secondary outcomes
Improvement post treatment as measured by the Modified Rankin Scale
Time frame: 2 weeks and 14 weeks
Improvement post treatment as measured by the NIH Stroke Scale
Time frame: 2 weeks and 14 weeks
Improvement post treatment as measured by the Stroke Impact Scale
Time frame: 2 weeks and 14 weeks
Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
Time frame: 2 weeks and 14 weeks
Improvement post treatment as measured by the Modified Ashworth Scale
Time frame: 2 weeks and 14 weeks
Improvement post treatment as measured by the Motor Activity Log
Time frame: 2 weeks and 14 weeks
Montreal Cognitive Assessment Test
Time frame: 2 weeks and 14 weeks
Structural Connectivity as measured by diffusion tensor imaging analysis
Time frame: 2 weeks
Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Time frame: 2 weeks
Improvement post treatment as measured by the Barthel index
Time frame: 2 week and 14 weeks
Safety of the intervention as assessed by frequency of adverse events
Time frame: 14 weeks
Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Time frame: 2 week and 14 weeks
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 27 Sep 2018.
- Derived from this study: PubMed 38922218Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Individual participant dataSharing planned: No. Deidentified imaging data will be shared with collaborators
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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 B Conforto, MD Phd principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and Physical Therapy in people with Stroke, run by Hospital Israelita Albert Einstein 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 4 inclusion and 11 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 27 Sep 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 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.
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?
Safety of the intervention as assessed by frequency of adverse events (time frame: 2 weeks). 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 NCT02455427, which also lists 2 linked publications.
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 27 Sep 2018.