StrokeNCT03529305
Effects of rTMS on Brain Alterations in Stroke Patients
A study testing rTMS and Physical therapy in people with Stroke, run by Hangzhou Normal University at 2 sites in China.
Trial summary
In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- rTMS and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever ischemic stroke
- One to six months after stroke onset;
- Mini Mental State Examination (MMSE) score > 24;
- Brunnstrom recovery stage (BRS) for hand fingers of 3-5
- Motor deficits of the unilateral upper limb
Who cannot join
- Patients with hemorrhage, leukoaraiosis, epilepsy, migraine or psychiatric diseases history are excluded in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Active, not recruiting
Hangzhou Normal University
Hangzhou, Zhejiang, 311121
- Recruiting
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210000
Haiyang Fu, Master, +86-13851905128, fhy112@sina.com
About this study
Official title: Effects of Different Frequency rTMS on Brain Functional and Structural Alterations in Stroke Patient: Multi-modal MRI Study
In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.
The patients will be randomized into three groups: Experimental group 1 (TMS group) received low frequency rTMS; Experimental group 2 (TMS group) received high frequency rTMS; The third group who received only physical therapy constituted the control group. All patients undergo MRI scan one day before and after rTMS treatment.
Read the detailed description
As the second leading cause of death and major cause of disability in the world, stroke is the rapid loss of brain function due to disturbance in the blood supply to the brain. Approximately two thirds of patients with stroke have impaired motor function even at three to six months after stroke onset. The abnormally increased interhemispheric inhibition driven from the unaffected to the affected hemisphere is associated with the motor impairment, which is characterized by increased cortical excitability in the unaffected hemisphere and decreased cortical excitability in the affected hemisphere. Rebalancing the cortical excitability between two hemispheres is associated with a better overall prognosis.
Repetitive transcranial magnetic stimulation (rTMS) is a painless, noninvasive brain stimulation technique. High-frequency rTMS facilitates cortical excitability, whereas low-frequency rTMS decreases the cortical excitability of the stimulated hemisphere. Therefore, rTMS can be used to increase and decrease the cortical excitability of the affected and unaffected hemispheres, respectively, and may facilitate motor function after stroke. However, the previous studies commonly applied behavioral scales to evaluate the effect of the rTMS treatment, little is known how the brain function and structure recover after rTMS treatment and whether the different frequency of rTMS will affect the recovery in the brain of stroke patients.
Non-invasive neuroimaging techniques provide promising avenues to detect brain function and structure in patients after stroke onset and have been increasingly applied to this disease. The morphology of the brain (cortical thickness, gray matter volume) is commonly assessed using T1-weighted MRI (Structural MRI). Diffusion tensor imaging (DTI) is a promising technique to study human brain structure, especially white matter anatomy, by providing multiple quantitative parameters to characterize tissue microstructure from different aspects. Functional magnetic resonance imaging (fMRI) is a functional neuroimaging technique which measures the changes of the blood oxygenation level-dependent (BOLD) signal that are highly correlated with neural activities. Task fMRI which applies stimulus-response pattern to identify the regions activated by performance of a cognitive task, while resting-state fMRI (rs-fMRI) is a promising tool to map intrinsic function of the human brain, which has unique advantages in clinical conditions because it does not require participants to engage in cognitive activities.
In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in stroke patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.
- Conditions
- Stroke
- Being tested
- rTMS, Physical therapy
- Keywords
- Stroke, rTMS, MRI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Receive rTMS treatment to the primary motor cortex (M1)
Physical therapyOther
Receive physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Low frequency rTMS | Experimental | Patients receive low frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the unaffected side for two weeks, 5 consecutive days each week. Receives: Device: rTMS; Other: Physical therapy |
| High frequency rTMS | Experimental | Patients receive high frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the affected side for two weeks, 5 consecutive days each week. Receives: Device: rTMS; Other: Physical therapy |
| Physical therapy | Active comparator | Patients receive physical therapy for two weeks. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain functional changes after rTMS treatment
Brain functional changes in patients' brain measured by fMRI
Measured: One day before and after two weeks' treatment
Brain morphological changes after rTMS treatment
Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI
Measured: One day before and after two weeks' treatment
Brain structural changes after rTMS treatment
White matter anatomical changes in patients' brain measured by DTI
Measured: One day before and after two weeks' treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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, Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yating Lv, PhD, Hangzhou Normal University
- Investigators
- Yu-Feng Zang, MD, Principal investigator, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529305
- Sponsor's protocol ID
- 2017YFC1310002
- Status last verified
- Aug 2019
- First submitted
- 19 Apr 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Frequency rTMS on Brain Functional and Structural Alterations in Stroke Patient: Multi-modal MRI Study
- ClinicalTrials.gov ID
- NCT03529305
- Acronym / sponsor ID
- 2017YFC1310002
- Conditions
- Stroke
- Keywords
- Stroke, rTMS, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 May 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, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.
The patients will be randomized into three groups: Experimental group 1 (TMS group) received low frequency rTMS; Experimental group 2 (TMS group) received high frequency rTMS; The third group who received only physical therapy constituted the control group. All patients undergo MRI scan one day before and after rTMS treatment.
Detailed description
As the second leading cause of death and major cause of disability in the world, stroke is the rapid loss of brain function due to disturbance in the blood supply to the brain. Approximately two thirds of patients with stroke have impaired motor function even at three to six months after stroke onset. The abnormally increased interhemispheric inhibition driven from the unaffected to the affected hemisphere is associated with the motor impairment, which is characterized by increased cortical excitability in the unaffected hemisphere and decreased cortical excitability in the affected hemisphere. Rebalancing the cortical excitability between two hemispheres is associated with a better overall prognosis.
Repetitive transcranial magnetic stimulation (rTMS) is a painless, noninvasive brain stimulation technique. High-frequency rTMS facilitates cortical excitability, whereas low-frequency rTMS decreases the cortical excitability of the stimulated hemisphere. Therefore, rTMS can be used to increase and decrease the cortical excitability of the affected and unaffected hemispheres, respectively, and may facilitate motor function after stroke. However, the previous studies commonly applied behavioral scales to evaluate the effect of the rTMS treatment, little is known how the brain function and structure recover after rTMS treatment and whether the different frequency of rTMS will affect the recovery in the brain of stroke patients.
Non-invasive neuroimaging techniques provide promising avenues to detect brain function and structure in patients after stroke onset and have been increasingly applied to this disease. The morphology of the brain (cortical thickness, gray matter volume) is commonly assessed using T1-weighted MRI (Structural MRI). Diffusion tensor imaging (DTI) is a promising technique to study human brain structure, especially white matter anatomy, by providing multiple quantitative parameters to characterize tissue microstructure from different aspects. Functional magnetic resonance imaging (fMRI) is a functional neuroimaging technique which measures the changes of the blood oxygenation level-dependent (BOLD) signal that are highly correlated with neural activities. Task fMRI which applies stimulus-response pattern to identify the regions activated by performance of a cognitive task, while resting-state fMRI (rs-fMRI) is a promising tool to map intrinsic function of the human brain, which has unique advantages in clinical conditions because it does not require participants to engage in cognitive activities.
In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in stroke patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low frequency rTMS | Experimental | Device: rTMS, Other: Physical therapyPatients receive low frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the unaffected side for two weeks, 5 consecutive days each week. |
| High frequency rTMS | Experimental | Device: rTMS, Other: Physical therapyPatients receive high frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the affected side for two weeks, 5 consecutive days each week. |
| Physical therapy | Active comparator | Other: Physical therapyPatients receive physical therapy for two weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-ever ischemic stroke
- One to six months after stroke onset;
- Mini Mental State Examination (MMSE) score > 24;
- Brunnstrom recovery stage (BRS) for hand fingers of 3-5
- Motor deficits of the unilateral upper limb
Key exclusion criteria (1 listed)
- Patients with hemorrhage, leukoaraiosis, epilepsy, migraine or psychiatric diseases history are excluded in this 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 |
|---|---|---|
| rTMSReceive rTMS treatment to the primary motor cortex (M1) | Device | High frequency rTMS, Low frequency rTMS |
| Physical therapyReceive physical therapy | Other | High frequency rTMS, Low frequency rTMS, Physical therapy |
Primary outcome
Brain functional changes after rTMS treatment
Time frame: One day before and after two weeks' treatment
Brain functional changes in patients' brain measured by fMRI
Brain morphological changes after rTMS treatment
Time frame: One day before and after two weeks' treatment
Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI
Brain structural changes after rTMS treatment
Time frame: One day before and after two weeks' treatment
White matter anatomical changes in patients' brain measured by DTI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Yu-Feng Zang, MD principal investigator
Hangzhou Normal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and Physical therapy in people with Stroke, run by Hangzhou Normal University at 2 sites in China.
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 1 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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 Yating Lv, PhD (+86-13396508848, lvyating198247@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain functional changes after rTMS treatment (time frame: One day before and after two weeks' 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?
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 Aug 2019.