Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283881
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-01-29
Brief Title:
Tactile Learning in Stroke Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Implicit Tactile Learning in Chronic Stroke Enhanced by Non-Invasive Brain Stimulation of the Somatosensory Cortex
Status:
COMPLETED
Status Verified Date:
2009-10-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine if stimulation of the stroke-injured side of the brain combined with stimulation to the paralyzed hand can temporarily improve the sense of touch in stroke patients
Healthy normal volunteers and people who have had a single stroke within 3 months of entering the study that affected one side of the brain may be eligible for this study All participants must be between 18 and 90 years old and must be right-handed Candidates are screened with a medical history neurological examination and magnetic resonance imaging MRI of the brain if one has not been done within 1 year of entering the study
Participants undergo the following tests and procedures during four 2-day sessions over about 6 weeks
Peripheral high-frequency stimulation Small loudspeakers are taped to the fingertips and simple tactile pulses are passed through the skin Stimulation may be sham or real
Transcranial direct current stimulation Two small rubber electrodes are taped to the head - one above the eye and the other on the back of the head A current is passed between the two electrodes Stimulation may be sham or real
MRI The subject lies in the scanner a metal cylinder surrounded by a magnetic field for about 40 minutes lying still for up to 40 minutes at a time An electrical stimulation is applied to the fingers of the right and left hand in separate sessions Earplugs are worn to muffle the loud noises during the scanning Functional MRI measures blood flow changes in the brain during the performance of specific tasks
Behavioral measurements
Grating orientation task The subject responds as quickly as possible to a touch stimulus to the finger by saying whether the direction of the stimulus is vertical or horizontal
Haptic object recognition task The subject is given five categories of unfamiliar objects in the shape of cubes During the task identical objects are hidden in a sack With eyes closed the subject is asked to identify and find the objects from the sack as quickly as possible
Pegboard test The subject is asked to place several pegs into a corresponding hole of a pegboard as soon as possible
Tapping task The subject is asked to tap a metal stick on a metal plate as quickly as possible for 1 minute
Paired-pulse transcranial magnetic stimulation This test measures changes in brain activity A wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The subject hears a click and may fee a pulling sensation on the skin under the coil and there may be a twitch in the muscles of the face arm or leg Subjects may be asked to tense certain muscles slightly or perform other simple actions
Paired-pulse somatosensory evoked potential mapping This test measures brain activity in another brain area The subject is seated in a chair with eyes closed One electrode is placed above the eye and two others are placed on the back of the head A short electrical stimulus is applied to a nerve in the wrist and brain activity is recorded while the stimulus is applied
Surface electromyography This test measures the electrical activity of muscles Electrodes are filed with a conductive gel and taped to the skin
Visual analog and mood scale Subjects complete questionnaires about their attention fatigue and mood
Healthy normal volunteers and people who have had a single stroke within 3 months of entering the study that affected one side of the brain may be eligible for this study All participants must be between 18 and 90 years old and must be right-handed Candidates are screened with a medical history neurological examination and magnetic resonance imaging MRI of the brain if one has not been done within 1 year of entering the study
Participants undergo the following tests and procedures during four 2-day sessions over about 6 weeks
Peripheral high-frequency stimulation Small loudspeakers are taped to the fingertips and simple tactile pulses are passed through the skin Stimulation may be sham or real
Transcranial direct current stimulation Two small rubber electrodes are taped to the head - one above the eye and the other on the back of the head A current is passed between the two electrodes Stimulation may be sham or real
MRI The subject lies in the scanner a metal cylinder surrounded by a magnetic field for about 40 minutes lying still for up to 40 minutes at a time An electrical stimulation is applied to the fingers of the right and left hand in separate sessions Earplugs are worn to muffle the loud noises during the scanning Functional MRI measures blood flow changes in the brain during the performance of specific tasks
Behavioral measurements
Grating orientation task The subject responds as quickly as possible to a touch stimulus to the finger by saying whether the direction of the stimulus is vertical or horizontal
Haptic object recognition task The subject is given five categories of unfamiliar objects in the shape of cubes During the task identical objects are hidden in a sack With eyes closed the subject is asked to identify and find the objects from the sack as quickly as possible
Pegboard test The subject is asked to place several pegs into a corresponding hole of a pegboard as soon as possible
Tapping task The subject is asked to tap a metal stick on a metal plate as quickly as possible for 1 minute
Paired-pulse transcranial magnetic stimulation This test measures changes in brain activity A wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The subject hears a click and may fee a pulling sensation on the skin under the coil and there may be a twitch in the muscles of the face arm or leg Subjects may be asked to tense certain muscles slightly or perform other simple actions
Paired-pulse somatosensory evoked potential mapping This test measures brain activity in another brain area The subject is seated in a chair with eyes closed One electrode is placed above the eye and two others are placed on the back of the head A short electrical stimulus is applied to a nerve in the wrist and brain activity is recorded while the stimulus is applied
Surface electromyography This test measures the electrical activity of muscles Electrodes are filed with a conductive gel and taped to the skin
Visual analog and mood scale Subjects complete questionnaires about their attention fatigue and mood
Detailed Description:
Chronic stroke is often accompanied by tactile impairments that contribute to long-term disability in activities of daily living While new rehabilitative interventions recently became available in the motor domain by using transcranial direct current stimulation tDCS there is no generally accepted treatment for tactile impairments after chronic stroke Previous studies in healthy volunteers demonstrated that tactile acuity and haptic skills can be improved by applying a passive learning protocol to the fingertip peripheral high-frequency stimulation pHFS Based on these findings the purpose of this protocol is to enhance the beneficial effect of pHFS on implicit tactile and haptic learning in chronic stroke patients by a combined application of pHFS with tDCS pHFStDCS applied to the somatosensory cortex of the affected hemisphere This approach might identify novel strategies to enhance functional recovery after stroke and might provide deeper insight into mechanistic information on the neural substrates involved in these behavioral gains Primary outcome measures will be performance in a tactile grating orientation discrimination task GOT and in a haptic object recognition task In order to obtain descriptive preliminary information on the relation between sensory improvements and motor deficits in chronic stroke patients secondary outcome measures will be fine motor tasks such as a tapping task and a pegboard test PBT that require manual dexterity handeye coordination steadiness and perceptual motor skills To identify the operating mechanisms underlying hypothesized performance improvements after pHFStDCS we will use paired-pulse protocols to evaluate changes in cortical excitability as well as fMRI in a subset of patients to identify cortical map reorganization in primary SI and secondary SII somatosensory cortex as well as in primary motor cortex MI Healthy volunteers will be tested a since there are no data available on performance of the haptic task in healthy subjects b to obtain descriptive information on the influence of our interventions on this task for hypothesis generation purposes in our future investigations and c because sensorimotor performance in the non-paretic hand of stroke patients is often not normal and therefore a poor sole control for performance of the paretic hand Studies in chronic stroke patients will help address the main experimental hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0080 | None | None | None |