Chronic StrokeNCT03481179
Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients
A study testing TMS and Physical therapy in people with Chronic Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- TMS and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to Apr 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 75 years;
- Both sexes;
- With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
- Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON \& SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
- With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)
Who cannot join
- Contraindications to and EMT (ROSSINI et al., 2015)
- Clinical evidence of multiple brain lesions
- Trauma-orthopedic injury that limits the range of motion of the upper limb
- Presence of visual and / or communication deficit
- Involvement of other interventions focused on reducing spasticity
- Modification of medications in the last 30 days.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Applied Neuroscience Laboratory
Recife, Pernambuco, 50740-560
Camilla Sales, PT, millabsales@gmail.com
Rebeca Dias, PT
About this study
Official title: Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients: Double Blinded, Randomized and Controlled Clinical
In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.
- Conditions
- Chronic Stroke
- Being tested
- TMS, Physical therapy
- Keywords
- Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called non invasive brain stimulation, high frequency rTMS
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Physical therapyOther
The physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM \& JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient
| Study group | Role | What they receive |
|---|---|---|
| Experimental: hf rTMS and Physical therapy | Experimental | High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol. Receives: Device: TMS; Other: Physical therapy |
| Control: Sham hf rTMS and Physical theraphy | Sham comparator | In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol. Receives: Device: TMS; Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity
Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.
Measured: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Secondary outcomes (7)
Cortical excitability
Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
Measured: before and after 10 daily sessions and after 30 days
Variation of the median nerve Hmax / Mmax ratio
The reflex H is an estimate of the excitability of the alpha motoneuron when there is a pre-synaptic inhibition (PALIERI, R.M et al., 2004). The variation of the H-reflex amplitude will evaluate the spinal cord excitability variation.
Measured: before and after 10 sessions and after 30 days
Sensory-motor function of the upper limb
This consists of a quantitative scale developed to measure the recovery of the motor function of stroke patients.Measured through the Fugl-Meyer Rating Scale. Expressed in values from 0 to 66;
Measured: before and after 10 daily sessions and after 30 days
Quality of life
Expressed in numerical values for each domain, the SSQOL has 49 items distributed in 12 domains (energy, family role, language, mobility, humor, personality, self-care, social role, reasoning, upper limb function, vision and work / productivity). There are three possibilities for responses that are quantified on a five-to-one scale.
Measured: before and after 10 daily sessions and after 30 days
Qualitative and quantitative of moviment
Motor Activity Log 30 (MAL-30) is a standardized instrument that was developed specifically to evaluate the function and use of the upper limb most affected post-stroke in the real-life environment (uncontrolled) through two scales: qualitative and quantitative. The total score is obtained by calculating the mean for each of the scales. The higher the mean obtained in the scales, the better the quality and quantity of use of the upper limb more affected in the accomplishment of the daily activities of life.
Measured: before and after 10 daily sessions and after 30 days
Dynamometry
It consists of an objective and quantitative way of measuring muscle shape using a manual portable dynamometer. The test will be performed with the Jamar dynamometer in KGF.
Measured: before and after 10 daily sessions and after 30 days
Changes on Patient Global Impression of Change Scale
Changes on Patient Global Impression of Change Scale - (time frame: baseline, before 6 session, after 10 sessions)
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
Measured: before and after 10 daily sessions and after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Aug 2017
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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, Investigator
- Enrolment
- 20 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
- Investigators
- Kátia Monte-Silva, PhD, Study director, Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481179
- Sponsor's protocol ID
- Stroke_High_rTMS
- Status last verified
- Mar 2018
- First submitted
- 1 Feb 2018
- Last updated
- 29 Mar 2018
- 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 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients: Double Blinded, Randomized and Controlled Clinical
- ClinicalTrials.gov ID
- NCT03481179
- Acronym / sponsor ID
- Stroke_High_rTMS
- Conditions
- Chronic Stroke
- Keywords
- Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 29 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.
In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: hf rTMS and Physical therapy | Experimental | Device: TMS, Other: Physical therapyHigh frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol. |
| Control: Sham hf rTMS and Physical theraphy | Sham comparator | Device: TMS, Other: Physical therapyIn this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30 to 75 years;
- Both sexes;
- With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
- Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON \& SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
- With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)
Key exclusion criteria (6 listed)
- Contraindications to and EMT (ROSSINI et al., 2015)
- Clinical evidence of multiple brain lesions
- Trauma-orthopedic injury that limits the range of motion of the upper limb
- Presence of visual and / or communication deficit
- Involvement of other interventions focused on reducing spasticity
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 |
|---|---|---|
| TMSAlso: non invasive brain stimulation, high frequency rTMSRepetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation. | Device | Control: Sham hf rTMS and Physical theraphy, Experimental: hf rTMS and Physical therapy |
| Physical therapyThe physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM \& JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient | Other | Control: Sham hf rTMS and Physical theraphy, Experimental: hf rTMS and Physical therapy |
Primary outcome
Spasticity
Time frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.
7 secondary outcomes
Cortical excitability
Time frame: before and after 10 daily sessions and after 30 days
Variation of the median nerve Hmax / Mmax ratio
Time frame: before and after 10 sessions and after 30 days
Sensory-motor function of the upper limb
Time frame: before and after 10 daily sessions and after 30 days
Quality of life
Time frame: before and after 10 daily sessions and after 30 days
Qualitative and quantitative of moviment
Time frame: before and after 10 daily sessions and after 30 days
Dynamometry
Time frame: before and after 10 daily sessions and after 30 days
Changes on Patient Global Impression of Change Scale
Time frame: before and after 10 daily sessions and after 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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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.
Kátia Monte-Silva, PhD study director
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS and Physical therapy in people with Chronic 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 5 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: status not confirmed, as of the sponsor's last update on 29 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 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 Monte-Silva, PhD (+55 81 988631322, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days). 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 29 Mar 2018.