Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | March 2015 |
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:
1. death of some brain cells in the affected side (hemisphere) of the brain
2. 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.
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. death of some brain cells in the affected side (hemisphere) of the brain
2. 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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- seizure within past two years
- metal in head (dental permitted)
- pregnancy
- psychiatric disorders
- receiving tricyclic antidepressants or neuroleptics
- inability to follow three-step command
- 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
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