| ID | Type | Description | Link |
|---|---|---|---|
| 12025-H13 | Other Identifier | Louis Stokes Cleveland VA Medical Center IRB |
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Stroke affects over 795,000 Americans every year and has an enormous impact on the well-being of American Veterans with 6,000 new stroke admissions every year. Many of these stroke survivors are living with disabilities that limit their everyday function. One of the major consequences of stroke is loss of sensation which manifests as inability to perceive touch, temperature, pain or limb movement. Lack of sensation hinders full functional recovery. Current treatments for sensory loss produce only limited improvements and do not achieve full recovery. Therefore, it is critical to develop new therapies to re-train sensory function. The investigators propose to evaluate a novel non-invasive brain stimulation treatment called repetitive Transcranial Magnetic Stimulation (rTMS). The effects of this technique on motor deficits following stroke have been studied, however rTMS for the treatment of sensory loss has not been examined to date. The investigators' study will examine for the first time if rTMS of a sensory brain region can improve sensory function in chronic stroke survivors.
Sensory deficits are present in the majority of stroke survivors. Inability to feel movement, touch or pain impairs the investigators' ability to interact with environment and diminished the quality of life. These sensory deficits significantly impair functional activity and slow down recovery during rehabilitation. Currently available sensory rehabilitation techniques can only partially restore sensory function. The main objective of this study is to test a novel approach to improve sensory function after stroke using non-invasive brain stimulation. This pilot study will measure an immediate effect of different repetitive Transcranial Magnetic Stimulation (rTMS) paradigms in a crossover single session design. The effect of intervention is measured with clinical measures of sensory and motor function and with neurophysiological assessment of sensory pathways. If the concept is demonstrated in this pilot study, then following the lead of other investigations of this type, this pilot will provide the foundation to test the efficacy of a long-term multi-session intervention of combined rTMS and peripherally directed therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High frequency rTMS | Other | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 5 Hz rTMS |
|
| Low frequency rTMS | Other | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was 1 Hz rTMS |
|
| Sham rTMS | Other | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study. One of the sessions was sham rTMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Other | 3 types of interventions on different sessions
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Two-point Discrimination | Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention. Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation. | up to 1 hour after intervention |
| Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency | Baseline measure is collected immediately before the intervention. Following each intervention, data is collected immediately after each intervention and at 1 hour after intervention. SEPs were recorded with a Cadwell Sierra Wave (Cadwell, Kennewick, WA) (LSCDVAMC) or with Powerlab 4/25T (AD Instruments Inc. Colorado Springs, CO) and a Grass Stimulator (Natus Neurology, Middleton, WI) (CC)44. The recording electrodes (1 cm diameter, gold cup electrodes filled with conductive paste) were placed 2 cm posterior to C3 & C4 (10-20 international system of EEG electrode placement) and the reference electrode at Fz (Figure 1). Stimulus was applied to the median nerve at the wrist. Ground electrodes were placed at the lateral epicondyle of the stimulated arm. The evoked response from 500 stimuli were recorded and averaged for a single trial. Three SEP trials were recorded then analyzed. Latencies (in milliseconds) were determined for N20. | up to 1 hour after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Svetlana Pundik, MD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33514270 | Result | Pundik S, Skelly M, McCabe J, Akbari H, Tatsuoka C, Plow EB. Does rTMS Targeting Contralesional S1 Enhance Upper Limb Somatosensory Function in Chronic Stroke? A Proof-of-Principle Study. Neurorehabil Neural Repair. 2021 Mar;35(3):233-246. doi: 10.1177/1545968321989338. Epub 2021 Jan 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stroke Cohort | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study repetitive transcranial magnetic stimulation (rTMS): 3 types of interventions on different sessions
peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stroke Cohort | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study repetitive transcranial magnetic stimulation (rTMS): 3 types of interventions on different sessions
peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Two-point Discrimination | Baseline measure is collected immediately before the intervention. There are two data collections following each intervention, one datacollection is immediately after the intervention and the second one is at 1 hour after intervention. Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation. | stroke cohort | Posted | Mean | Standard Deviation | mm | up to 1 hour after intervention |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Frequency rTMS | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 5Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Svetlana Pundik | VA Northeast Ohio Healthcare System | (216)791-3800 | svetlana.pundik@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2019 | Oct 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006987 | Hypesthesia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| peripheral sensory stimulation | Other | peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| two point discrimination | Two-point discrimination was measured with Disk-Criminator disks (Baltimore, MD) by determining the subjects' ability to perceive two points on the disk as two separate points rather than as a single point. The distances between the two points ranged between 2 and 15 mm. One and two sensory points were presented in a pseudo-random order to subjects' 4th digit volar fingertip surface. A threshold is determined when seventy percent accuracy is exhibited for identifying the difference between single versus double point stimulation. | Mean | Standard Deviation | mm |
|
Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study
For these sessions, participants received 5Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
| OG001 | Low Frequency rTMS | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 1Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS |
| OG002 | Sham rTMS | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received sham Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS |
|
|
| Primary | Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency | Baseline measure is collected immediately before the intervention. Following each intervention, data is collected immediately after each intervention and at 1 hour after intervention. SEPs were recorded with a Cadwell Sierra Wave (Cadwell, Kennewick, WA) (LSCDVAMC) or with Powerlab 4/25T (AD Instruments Inc. Colorado Springs, CO) and a Grass Stimulator (Natus Neurology, Middleton, WI) (CC)44. The recording electrodes (1 cm diameter, gold cup electrodes filled with conductive paste) were placed 2 cm posterior to C3 & C4 (10-20 international system of EEG electrode placement) and the reference electrode at Fz (Figure 1). Stimulus was applied to the median nerve at the wrist. Ground electrodes were placed at the lateral epicondyle of the stimulated arm. The evoked response from 500 stimuli were recorded and averaged for a single trial. Three SEP trials were recorded then analyzed. Latencies (in milliseconds) were determined for N20. | stroke cohort | Posted | Mean | Standard Deviation | msec | up to 1 hour after intervention |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Low Frequency rTMS | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received 1Hz rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Sham rTMS | Each subject is provided with three different brain stimulation interventions in a single arm, single session crossover design study For these sessions, participants received sham rTMS targeting contralesional sensory cortex and peripheral sensory stimulation: peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS | 0 | 16 | 0 | 16 | 0 | 16 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|