StrokeNCT00283881
Tactile Learning in Stroke Patients
An observational study of Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2006to 7 Oct 2009
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We will include left- and right-handed stroke patients, aged 18-90 years, with thromboembolic or hemorrhagic hemispheric lesions at least 3 months after the stroke. We will choose patients who initially had a severe motor paresis (below MRC grade 2), and subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks. Moreover, only chronic stroke patients with moderate tactile deficits (defined by absolute touch thresholds below 4 N using von Frey filaments) who are able to differentiate the alignment of a grating dome (either orthogonal or parallel to the index finger) of at least 5 mm grooves that is applied on the fingertip will be included in the protocol.
- Assessment of the initial functional state will be taken either from patient reports or medical records. Right-handed healthy volunteers, aged 18-90 years, should be able to concentrate on the required tasks. Handedness will be assessed by the Edinburgh inventory scale as well as the hand dominance test (HDT). We will additionally perform a pregnancy test for women of child-bearing potential. All experimental sessions will be on outpatient basis.
Who cannot join
- Chronic stroke patients will be not be eligible for the study if they:
- are unable to perform the behavioral tasks,
- have a sensory neglect,
- have had more than one clinical stroke,
- have both sides of the brain affected,
- have had a stroke in the cerebellum or brainstem,
Show all 18Show fewer
- have a history of alcohol or drug abuse or severe language disturbances or serious cognitive deficits,
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- have severe tactile deficits (defined by Frey filaments exerting a force of 4 N to the distal pad of the finger on the paretic and non-paretic hand),
- are pregnant,
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium, with the exception of dental braces in the mouth.
- Healthy volunteers will not be eligible for the study if they:
- are unable to perform the tasks,
- have a history of alcohol or drug abuse or severe language disturbances or serious cognitive deficits,
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- have severe tactile deficits (defined by Frey filaments exerting a force of 4 N to the distal pad of the finger),
- are pregnant,
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium except in the mouth, dental braces.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Implicit Tactile Learning in Chronic Stroke Enhanced by Non-Invasive Brain Stimulation of the Somatosensory Cortex
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.
Read more
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.
Read the 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 (pHFS+tDCS) 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 pHFS+tDCS, 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.
- Conditions
- Stroke
- Keywords
- Haptic Skills, Implicit Tactile Learning, Functional Magnetic Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), Stroke, Healthy Volunteer, HV
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study start25 Jan 2006
- Primary completion7 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283881
- Sponsor's protocol ID
- 060080
- Other IDs
- 06-N-0080
- Status last verified
- 7 Oct 2009
- First submitted
- 29 Jan 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
PubMed 15634731Vega A. Use of Purdue pegboard and finger tapping performance as a rapid screening test for brain damage. J Clin Psychol. 1969 Jul;25(3):255-8. doi: 10.1002/1097-4679(196907)25:33.0.co;2-v. No abstract available.
PubMed 5803245Mansur CG, Fregni F, Boggio PS, Riberto M, Gallucci-Neto J, Santos CM, Wagner T, Rigonatti SP, Marcolin MA, Pascual-Leone A. A sham stimulation-controlled trial of rTMS of the unaffected hemisphere in stroke patients. Neurology. 2005 May 24;64(10):1802-4. doi: 10.1212/01.WNL.0000161839.38079.92.
PubMed 15911819
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implicit Tactile Learning in Chronic Stroke Enhanced by Non-Invasive Brain Stimulation of the Somatosensory Cortex
- ClinicalTrials.gov ID
- NCT00283881
- Acronym / sponsor ID
- 060080
- Conditions
- Stroke
- Keywords
- Haptic Skills, Implicit Tactile Learning, Functional Magnetic Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), Stroke, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 25 Jan 2006
- Primary completion
- 7 Oct 2009 (actual)
- First posted
- 30 Jan 2006 (estimated)
- 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.
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.
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 (pHFS+tDCS) 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 pHFS+tDCS, 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 design
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- We will include left- and right-handed stroke patients, aged 18-90 years, with thromboembolic or hemorrhagic hemispheric lesions at least 3 months after the stroke. We will choose patients who initially had a severe motor paresis (below MRC grade 2), and subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks. Moreover, only chronic stroke patients with moderate tactile deficits (defined by absolute touch thresholds below 4 N using von Frey filaments) who are able to differentiate the alignment of a grating dome (either orthogonal or parallel to the index finger) of at least 5 mm grooves that is applied on the fingertip will be included in the protocol.
- Assessment of the initial functional state will be taken either from patient reports or medical records. Right-handed healthy volunteers, aged 18-90 years, should be able to concentrate on the required tasks. Handedness will be assessed by the Edinburgh inventory scale as well as the hand dominance test (HDT). We will additionally perform a pregnancy test for women of child-bearing potential. All experimental sessions will be on outpatient basis.
Key exclusion criteria (18 listed)
- are unable to perform the behavioral tasks,
- have a sensory neglect,
- have had more than one clinical stroke,
- have both sides of the brain affected,
- have had a stroke in the cerebellum or brainstem,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15634731Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
- Background: PubMed 5803245Vega A. Use of Purdue pegboard and finger tapping performance as a rapid screening test for brain damage. J Clin Psychol. 1969 Jul;25(3):255-8. doi: 10.1002/1097-4679(196907)25:33.0.co;2-v. No abstract available.
- Background: PubMed 15911819Mansur CG, Fregni F, Boggio PS, Riberto M, Gallucci-Neto J, Santos CM, Wagner T, Rigonatti SP, Marcolin MA, Pascual-Leone A. A sham stimulation-controlled trial of rTMS of the unaffected hemisphere in stroke patients. Neurology. 2005 May 24;64(10):1802-4. doi: 10.1212/01.WNL.0000161839.38079.92.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 2 inclusion and 18 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 2 Jul 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283881, which also lists 3 linked publications.
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 2 Jul 2017.