Cerebrovascular Accident, Hemiparesis, Stroke
Conditions
Keywords
Neuromodulation, Transcranial magnetic stimulation (TMS), Electrical stimulation
Brief summary
The objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. Muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the spinal cord that cause muscles to produce movement. The neuromodulation strategy central to this project has been shown the strengthen the physical connection between both cells, producing a change in movement potential of muscles weakened by stroke.
Detailed description
Stroke is a leading cause of serious long-term disability in the United States with 795,000 individuals suffering a new or recurrent stroke each year. In most cases, disability is associated with incomplete motor recovery of the paretic limb. Full recovery is often not achieved, creating a need for neuromodulation strategies that target the physiological mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system. The neuromodulation protocol that will be tested in these experiments will target connections between the brain and spinal cord with noninvasive stimulation to enhance movement potential of the hand. Individuals who experienced a single stroke at least 6 months ago may be eligible to participate.
Interventions
OTHERPaired corticospinal-motoneuronal stimulation (PCMS)
Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity.
OTHERSham stimulation
Synapses in the spinal cord that transmit voluntary movement commands from the brain to hand muscles will not be activated by noninvasive stimulation in a particular sequence and interval that has been shown to strengthen connectivity.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Transcranial magnetic stimulation targeting the region of the brain responsible for voluntary movement control and electrical stimulation to a peripheral nerve innervating hand muscles will be triggered at an interval that elicits action potentials arriving in a set sequence and predetermined delay in the spinal cord.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 75 years old * Diagnosis of first-ever stroke * Stroke onset of at least six months prior to the time of participation
Exclusion criteria
* History of seizure or epilepsy * Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for subjects undergoing MRI) * Pregnant or expecting to become pregnant * Difficulty maintaining alertness and/or remaining still * Body weight \> 300 lbs due to MRI scanner dimensions (for subjects undergoing MRI) * Cognitive or language impairments that would interfere with the ability to follow simple instructions, as judged by the investigators * Diagnosis of movement disorder(s) other than stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Control & Learning | Measured under each condition, with approximately 2 months required for completion of all conditions. | A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Condition 1. Rest PCMS: PCMS was administered with the targeted hand muscles at rest.
2. Sham: Peripheral nerve stimulation was administered and the stimulating coil discharged when subjects achieved a criterion level of force stability during task repetition. The stimulating coil was rotated to prevent activation of the brain, thus, preventing PCMS.
3. Active PCMS: PCMS was administered when subjects achieved a criterion level of force stability during task repetition. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Condition |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
Primary
Motor Control & Learning
A force tracking task will be performed and a measure of variability about the mean force required by the force to be tracked will be computed.
Time frame: Measured under each condition, with approximately 2 months required for completion of all conditions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rest PCMS | Motor Control & Learning | 0.339 Newton | Standard Error 0.141 |
| Sham PCMS | Motor Control & Learning | 0.359 Newton | Standard Error 0.139 |
| Active PCMS | Motor Control & Learning | 0.301 Newton | Standard Error 0.115 |