StrokeNCT01922986
Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke
A study testing active rTMS and conventional stroke therapy in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial summary
When a certain area of the brain is injured, like in stroke, several events occur. One side of the body may become weak. This weakness is called hemiparesis and it may create difficulty in performing tasks like writing, eating, and walking. The weakness results from two sources: 1. 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 rTMS and conventional stroke therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- stroke onset: within past 30 days but rTMS intervention will commence no sooner than 5 days from stroke onset
- stroke location: cortical or subcortical
- stroke type: ischemic
- age: >18 years
- paretic index finger must show either no or impaired flexion/extension motion at the metacarpophalangeal (MP) joint.
- Mini-Mental State Examination greater than or equal to 22
- ability to stand/transfer with no more than moderate assistance
Who cannot join
- seizure within past two years
- metal in head (dental permitted)
- pregnancy
- psychiatric disorders
- receiving tricyclic antidepressants or neuroleptics
- inability to follow three-step command
Show all 10Show fewer
- hemineglect
- dependent on ventilator, nasogastric tube, or implanted medical device
- co-morbidities impairing upper extremity function
- anticipated stay at Courage Kenny Rehabilitation Institute shorter than 7 treatment days
Trial locations and contacts
1 site in 1 country.
United States1 site
Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, 55407
About this study
Official title: Real vs Sham rTMS Combined With Conventional Therapy in Acute Stroke
When a certain area of the brain is injured, like in stroke, several events occur. One side of the body may become weak. This weakness is called hemiparesis and it may create difficulty in performing tasks like writing, eating, and walking. The weakness results from two sources:
- death of some brain cells in the affected side (hemisphere) of the brain
- exaggerated inhibitory signals from the unaffected hemisphere acting on surviving neurons in the affected hemisphere.
Investigators cannot change neurons that have died but they may be able to change the exaggerated inhibition that impairs the surviving neurons in the affected hemisphere.The purpose of this study is to try to decrease the exaggerated inhibition coming from the unaffected hemisphere, which suppresses the affected hemisphere, with transcranial magnetic stimulation (TMS). Investigators hypothesize that, from admission to discharge, active rTMS combined with conventional therapy will produce greater functional gains in the paretic hand compared to sham rTMS combined with conventional therapy, as measured by standard tests.
Read the detailed description
Stroke is the leading cause of long-term disability in the United States and people with stroke deserve our maximum effort to restore in them as much function as possible; yet, mainstream stroke rehabilitation remains mired in traditional treatment approaches that may be suboptimal. However, for the past 5 years we have been endeavoring to advance stroke rehabilitation by including noninvasive brain stimulation. This study will explore whether the safety and functional results from noninvasive brain stimulation in patients with chronic stroke when given by researchers in a laboratory setting can be replicated in acute stroke when given by trained clinicians in the real-world clinical setting.
As background, a phenomenon in stroke is that compensatory overuse of the non-stroke hemisphere can inhibit surviving neurons in the stroke hemisphere. In this way, people with stroke are "doubly disabled" - first, by the stroke itself and, second, by exaggerated interhemispheric inhibition (IHI) arising in the non-stroke hemisphere and acting on surviving neurons in the non-stroke hemisphere. Investigators cannot bring the killed neurons back to life but they can up-regulate the surviving neurons suppressed by IHI. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive way to do this.
rTMS has not yet entered mainstream clinical use for stroke, likely because it has not been explored in the acute rehabilitation setting with application by clinicians. With prior National Institutes of Health funding, Dr. Carey has considerable experience in using rTMS in the laboratory setting for chronic stroke. He will now take rTMS out of his lab and into the real-world setting of Courage Kenny Rehabilitation Institute (CKRI), the primary referral center for acute stroke rehabilitation in our region, where clinicians will be trained in rTMS. Five daily rTMS treatments (active or sham) will be given to the non-stroke primary motor area (M1). After each treatment, patients will receive their conventional rehabilitation training. This approach is innovative because of the rTMS parameters used and because the application will be given by trained clinicians with oversight by the Principal Investigator, as opposed to laboratory researchers. Expected outcomes are improved hand function with no major adverse effects. Data will serve as a springboard to larger clinical trials.
Specific Aim #1: Determine the safety of 5 treatments of 6-Hz primed low-frequency rTMS combined with conventional therapy in adults with acute stroke.
Adverse effects will be measured through observation for seizures, investigator screening, physician exam, and tests of cognitive function and motor function in the nonparetic hand.
Investigators hypothesize there will be a) no seizures, b) no cognitive decline and c) no motor decline.
Specific Aim #2: Compare the effectiveness of active vs. sham rTMS on functional outcomes in adults with acute stroke.
Adults with acute stroke will be randomized to receive either active rTMS or sham rTMS. Both groups will also receive conventional therapy, consisting of the normal rehabilitation used at this rehabilitation center. Investigators hypothesize that, from admission to discharge, active rTMS will produce greater functional gains in the paretic hand compared to sham rTMS, as measured by standard tests.
- Conditions
- Stroke
- Being tested
- active rTMS, sham rTMS, conventional stroke therapy
- Keywords
- stroke, rehabilitation, hemiplegia, repetitive transcranial magnetic stimulation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSDevice
10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
sham rTMSDevice
20 minutes of sham rTMS stimulation
conventional stroke therapyBehavioural
conventional stroke therapy consisting of exercises and physical training
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS with conventional therapy | Experimental | 20 minutes of active rTMS followed by conventional stroke therapy Receives: Device: active rTMS; Behavioral: conventional stroke therapy |
| sham rTMS with conventional therapy | Sham comparator | 20 minutes of sham rTMS stimulation followed by conventional stroke therapy Receives: Device: sham rTMS; Behavioral: conventional stroke therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores
This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests
Measured: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
Secondary outcomes (2)
Change in Finger Tracking Test
This test involves placing a device on the hand that shows the changing angle of the finger joint on a computer screen as the joint is moved. The computer screen also shows a target line, such as a sine wave. At the start of the test, the computer screen cursor moves horizontally across the target and the subject moves the finger joint into extension or flexion to adjust the vertical position of the cursor to that it traces the target line as accurately as possible. The performance is quantified by calculating the root-mean-square error between the target line and the response line. This is converted into an Accuracy Index, which has a maximum value of 100% (perfect score). Negative values can occur and reach a value of -100%, signifying very poor performance. Typical scores for healthy range from 50-80%. Typical values in stroke range from -100 to +40%. Changes that are positive signify increased tracking accuracy at posttest compared to pretest, which would be an improvement.
Measured: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
Change in Motricity Index
Measures strength in finger pinch, elbow flexion and arm abduction. 0 No pinch movement. 11 Slight movement of finger or thumb. 19 Able to grip the cube, but not hold it against gravity. 22 Able to grip and hold the cube against gravity, but not against a weak pull by examiner.
The weighted score based on the ordinal 6 point scale 26 Able to grip and hold the cube against a weak pull, but weaker than the other side.
33 Normal pinch grip.
For shoulder and elbow scoring is:
0 No movement. 9 Palpable contraction in muscle, but no movement. 14 Visible movement, but not full range and not against gravity. 19 Full range of movement against gravity but not against resistance. 25 Full movement against resistance, but weaker than the other side. 33 Normal power. Maximum total score is 99, minimum is 0. Changes that are positive signify improved strength at postte
Measured: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Carey, PhD, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922986
- Sponsor's protocol ID
- Acute_rTMS
- Status last verified
- Apr 2017
- First submitted
- 26 Jul 2013
- Last updated
- 25 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real vs Sham rTMS Combined With Conventional Therapy in Acute Stroke
- ClinicalTrials.gov ID
- NCT01922986
- Acronym / sponsor ID
- Acute_rTMS
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, hemiplegia, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a certain area of the brain is injured, like in stroke, several events occur. One side of the body may become weak. This weakness is called hemiparesis and it may create difficulty in performing tasks like writing, eating, and walking. The weakness results from two sources:
- death of some brain cells in the affected side (hemisphere) of the brain
- exaggerated inhibitory signals from the unaffected hemisphere acting on surviving neurons in the affected hemisphere.
Investigators cannot change neurons that have died but they may be able to change the exaggerated inhibition that impairs the surviving neurons in the affected hemisphere.The purpose of this study is to try to decrease the exaggerated inhibition coming from the unaffected hemisphere, which suppresses the affected hemisphere, with transcranial magnetic stimulation (TMS). Investigators hypothesize that, from admission to discharge, active rTMS combined with conventional therapy will produce greater functional gains in the paretic hand compared to sham rTMS combined with conventional therapy, as measured by standard tests.
Detailed description
Stroke is the leading cause of long-term disability in the United States and people with stroke deserve our maximum effort to restore in them as much function as possible; yet, mainstream stroke rehabilitation remains mired in traditional treatment approaches that may be suboptimal. However, for the past 5 years we have been endeavoring to advance stroke rehabilitation by including noninvasive brain stimulation. This study will explore whether the safety and functional results from noninvasive brain stimulation in patients with chronic stroke when given by researchers in a laboratory setting can be replicated in acute stroke when given by trained clinicians in the real-world clinical setting.
As background, a phenomenon in stroke is that compensatory overuse of the non-stroke hemisphere can inhibit surviving neurons in the stroke hemisphere. In this way, people with stroke are "doubly disabled" - first, by the stroke itself and, second, by exaggerated interhemispheric inhibition (IHI) arising in the non-stroke hemisphere and acting on surviving neurons in the non-stroke hemisphere. Investigators cannot bring the killed neurons back to life but they can up-regulate the surviving neurons suppressed by IHI. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive way to do this.
rTMS has not yet entered mainstream clinical use for stroke, likely because it has not been explored in the acute rehabilitation setting with application by clinicians. With prior National Institutes of Health funding, Dr. Carey has considerable experience in using rTMS in the laboratory setting for chronic stroke. He will now take rTMS out of his lab and into the real-world setting of Courage Kenny Rehabilitation Institute (CKRI), the primary referral center for acute stroke rehabilitation in our region, where clinicians will be trained in rTMS. Five daily rTMS treatments (active or sham) will be given to the non-stroke primary motor area (M1). After each treatment, patients will receive their conventional rehabilitation training. This approach is innovative because of the rTMS parameters used and because the application will be given by trained clinicians with oversight by the Principal Investigator, as opposed to laboratory researchers. Expected outcomes are improved hand function with no major adverse effects. Data will serve as a springboard to larger clinical trials.
Specific Aim #1: Determine the safety of 5 treatments of 6-Hz primed low-frequency rTMS combined with conventional therapy in adults with acute stroke.
Adverse effects will be measured through observation for seizures, investigator screening, physician exam, and tests of cognitive function and motor function in the nonparetic hand.
Investigators hypothesize there will be a) no seizures, b) no cognitive decline and c) no motor decline.
Specific Aim #2: Compare the effectiveness of active vs. sham rTMS on functional outcomes in adults with acute stroke.
Adults with acute stroke will be randomized to receive either active rTMS or sham rTMS. Both groups will also receive conventional therapy, consisting of the normal rehabilitation used at this rehabilitation center. Investigators hypothesize that, from admission to discharge, active rTMS will produce greater functional gains in the paretic hand compared to sham rTMS, as measured by standard tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS with conventional therapy | Experimental | Device: active rTMS, Behavioral: conventional stroke therapy20 minutes of active rTMS followed by conventional stroke therapy |
| sham rTMS with conventional therapy | Sham comparator | Device: sham rTMS, Behavioral: conventional stroke therapy20 minutes of sham rTMS stimulation followed by conventional stroke therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- stroke onset: within past 30 days but rTMS intervention will commence no sooner than 5 days from stroke onset
- stroke location: cortical or subcortical
- stroke type: ischemic
- age: >18 years
- paretic index finger must show either no or impaired flexion/extension motion at the metacarpophalangeal (MP) joint.
Key exclusion criteria (10 listed)
- seizure within past two years
- metal in head (dental permitted)
- pregnancy
- psychiatric disorders
- receiving tricyclic antidepressants or neuroleptics
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 rTMS10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600). | Device | Active rTMS with conventional therapy |
| sham rTMS20 minutes of sham rTMS stimulation | Device | sham rTMS with conventional therapy |
| conventional stroke therapyconventional stroke therapy consisting of exercises and physical training | Behavioural | Active rTMS with conventional therapy, sham rTMS with conventional therapy |
Primary outcome
Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores
Time frame: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests
2 secondary outcomes
Change in Finger Tracking Test
Time frame: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
Change in Motricity Index
Time frame: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
James R Carey, PhD, PT principal investigator
University of Minnesota
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 rTMS and conventional stroke therapy in people with Stroke, run by University of Minnesota at 1 site in United States.
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 7 inclusion and 10 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 25 May 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores (time frame: Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).). 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 25 May 2017.