StrokeNCT04816305
Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
A study testing rTMSc and Neurofunctional physiotherapy in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- rTMSc and Neurofunctional physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Mar 2021to 30 Jun 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 3 months after stroke;
- Ischemic or hemorrhagic stroke with upper limb motor impairment;
Who cannot join
- Any contraindication for application of transcranial magnetic stimulation;
- Peripheral lesions in the assessed upper limb;
- Score ≤ 18 at Folstein Mini Mental State Examination;
- Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
- Application of botulinum toxin in less than 6 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Pernambucano
Recife, Pernambuco, 50740-560
Katia Monte-Silva, PhD, +55(81)21267579, monte.silvakk@gmail.com
About this study
Official title: Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.
Read the detailed description
After the patients and volunteers signed an informed consent form they will be classified and randomized using a website (randomization.com) by a non-involved researcher.
All patients and volunteers will be assigned to groups (arms) after being tried:
(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;
In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.
- Conditions
- Stroke
- Being tested
- rTMSc, Neurofunctional physiotherapy, rTMS sham
- Keywords
- Transcranial magnetic stimulation, Electroencephalogram, Physiotherapy, Brain symmetry, Biomarker
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMScDevice
In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
Neurofunctional physiotherapyBehavioural
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
rTMS shamDevice
During the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| rTMSc + physiotherapy | Experimental | A conventional high-frequency rTMS (rTMSc) will be applied over the lesioned hemisphere over the motor cortex. After rTMSc, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks. Receives: Device: rTMSc; Behavioral: Neurofunctional physiotherapy |
| rTMSp + physiotherapy | Experimental | A personalized high or low-frequency rTMS (rTMSp) will be applied to the lesioned or non-lesioned hemisphere depending on cortical biomarkers assessment guide a personalized stimulation for each patient in this group. After rTMSp, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks. Receives: Device: rTMSc; Behavioral: Neurofunctional physiotherapy |
| tDCS sham + physiotherapy | Sham comparator | The sham protocol will be delivered to each patient of this arm imitating the exat sound of the equipment and structure of the experimental arms. After rTMS sham, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks. Receives: Behavioral: Neurofunctional physiotherapy; Device: rTMS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain symmetry (baseline)
Accessed with:
Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (> 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz); beta (> 13 a ≤ 30 Hz); gama (< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
Measured: Before each session (10 sessions for 5 days a week for two weeks)
Brain symmetry (post-treatment)
Accessed with:
Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (> 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz); beta (> 13 a ≤ 30 Hz); gama (< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
Measured: After each session (10 sessions for 5 days a week for two weeks)
Brain symmetry (baseline)
Accessed with:
Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.
Measured: Before each session (10 sessions for 5 days a week for two weeks)
Brain symmetry (post-treatment)
Accessed with:
Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.
Measured: After each session (10 sessions for 5 days a week for two weeks)
Secondary outcomes (3)
Change in Fugl Meyer assesment of paretic upper limb motor function
Fugl Meyer assesment is used to measure motor control recovery. It is a 226 point scoring system that includes the following sessions: range of motion, pain, sensation,motor function of upper and lower limbs, balance, coordination and velocity. We will apply only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points. Higher scores indicates better outcomes
Measured: 10 sessions (5 days a week for two weeks)
Modified Ashworth Scale
The modified Ashworth scale is a 6-point rating scale that is used to measure muscle tone and it will be used to determine the spasticity wrist flexor muscles in the affected hand by stroke. It evaluates the antagonist muscles that limits the force of agonist muscled during a intended motion.
Measured: 10 sessions (5 days a week for two weeks)
The National Institutes of Health Stroke
This scale will determine the severity and disability level of the post-stroke patient; which consists of 15 items that assess the domains: level of consciousness, eye movements, visual field, facial movements, motor function and ataxia of upper and lower limbs, as well as sensitivity, language, presence of dysarthria and spatial neglect. Each domain punctuates a specific skill from 0 (zero) to 4 points that may vary until a maximum of 42 points.
Measured: 10 sessions (5 days a week for two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start29 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816305
- Sponsor's protocol ID
- TMS_biomarkers_stroke
- Status last verified
- May 2023
- First submitted
- 22 Oct 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
- ClinicalTrials.gov ID
- NCT04816305
- Acronym / sponsor ID
- TMS_biomarkers_stroke
- Conditions
- Stroke
- Keywords
- Transcranial magnetic stimulation, Electroencephalogram, Physiotherapy, Brain symmetry, Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Mar 2021 (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.
This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.
Detailed description
After the patients and volunteers signed an informed consent form they will be classified and randomized using a website (randomization.com) by a non-involved researcher.
All patients and volunteers will be assigned to groups (arms) after being tried:
(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;
In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMSc + physiotherapy | Experimental | Device: rTMSc, Behavioral: Neurofunctional physiotherapyA conventional high-frequency rTMS (rTMSc) will be applied over the lesioned hemisphere over the motor cortex. After rTMSc, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks. |
| rTMSp + physiotherapy | Experimental | Device: rTMSc, Behavioral: Neurofunctional physiotherapyA personalized high or low-frequency rTMS (rTMSp) will be applied to the lesioned or non-lesioned hemisphere depending on cortical biomarkers assessment guide a personalized stimulation for each patient in this group. After rTMSp, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks. |
| tDCS sham + physiotherapy | Sham comparator | Behavioral: Neurofunctional physiotherapy, Device: rTMS shamThe sham protocol will be delivered to each patient of this arm imitating the exat sound of the equipment and structure of the experimental arms. After rTMS sham, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 3 months after stroke;
- Ischemic or hemorrhagic stroke with upper limb motor impairment;
Key exclusion criteria (5 listed)
- Any contraindication for application of transcranial magnetic stimulation;
- Peripheral lesions in the assessed upper limb;
- Score ≤ 18 at Folstein Mini Mental State Examination;
- Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
- Application of botulinum toxin in less than 6 months.
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 |
|---|---|---|
| rTMScIn all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts. | Device | rTMSc + physiotherapy, rTMSp + physiotherapy |
| Neurofunctional physiotherapyAll patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study. | Behavioural | rTMSc + physiotherapy, rTMSp + physiotherapy, tDCS sham + physiotherapy |
| rTMS shamDuring the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off. | Device | tDCS sham + physiotherapy |
Primary outcome
Brain symmetry (baseline)
Time frame: Before each session (10 sessions for 5 days a week for two weeks)
Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (> 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz); beta (> 13 a ≤ 30 Hz); gama (< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
Brain symmetry (post-treatment)
Time frame: After each session (10 sessions for 5 days a week for two weeks)
Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (> 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz); beta (> 13 a ≤ 30 Hz); gama (< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
Brain symmetry (baseline)
Time frame: Before each session (10 sessions for 5 days a week for two weeks)
Accessed with: Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.
Brain symmetry (post-treatment)
Time frame: After each session (10 sessions for 5 days a week for two weeks)
Accessed with: Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.
3 secondary outcomes
Change in Fugl Meyer assesment of paretic upper limb motor function
Time frame: 10 sessions (5 days a week for two weeks)
Modified Ashworth Scale
Time frame: 10 sessions (5 days a week for two weeks)
The National Institutes of Health Stroke
Time frame: 10 sessions (5 days a week for two weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMSc and Neurofunctional physiotherapy in people with Stroke, run by Universidade Federal de Pernambuco 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 5 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kátia Karina Monte-Silva, PhD (+558121267579, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain symmetry (baseline) (time frame: Before each session (10 sessions for 5 days a week for two weeks)). The study lists 4 primary outcomes in all. 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 10 May 2023.