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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD100416 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The investigators performed a feasibility trial of operant conditioning of spinal reflex excitability on five healthy individuals and two post-stroke individuals. The investigators found that operant conditioning of rectus femoris reflex excitability was feasible in all participants.
The investigators performed a cohort study on 7 individuals (5 healthy, 2 post-stroke) to examine the feasibility of operant down-conditioning of rectus femoris reflex excitability (i.e. H-reflex). Each individual performed 30 sessions, 6 baseline sessions with no operant conditioning (225 trials of surface electrical stimulation of the femoral nerve), followed by 24 training sessions (20 baseline trials followed by 225 trials with feedback of H-reflex magnitude). The investigators' main outcome measure was rectus femoris H-reflex magnitude. We also examined H-reflex magnitude of other quadriceps muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training group | Experimental | Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operant RF H-reflex conditioning | Behavioral | Operant down-conditioning of rectus femoris H-reflex |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in RF H-reflex Magnitude | H-reflex magnitude of rectus femoris. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's rectus femoris of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in VM H-reflex Magnitude | H-reflex magnitude of vastus medialis. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's vastus medialis of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Austin | Texas | 78712 | United States |
Unidentified data available upon reasonable request
3 years
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There were no other factors considered in addition to already stated inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Training Group | Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. Operant RF H-reflex conditioning: Operant down-conditioning of rectus femoris H-reflex |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Training Group | Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. Operant RF H-reflex conditioning: Operant down-conditioning of rectus femoris H-reflex |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage Change From Baseline in RF H-reflex Magnitude | H-reflex magnitude of rectus femoris. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's rectus femoris of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period. | Posted | Mean | Standard Error | percentage change in reflex size | 3 months |
|
3 months of data acquisition per individual participant
We monitored adverse events reported from individuals
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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 | Training Group | Participants receive 24 sessions of operant H-reflex conditioning of the rectus femoris. Operant RF H-reflex conditioning: Operant down-conditioning of rectus femoris H-reflex |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Sulzer | MetroHealth Hospital/Case Western Reserve University | 5125419036 | jss280@case.edu |
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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 | Jul 28, 2021 | Feb 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2021 | Feb 12, 2024 | ICF_001.pdf |
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| 3 months |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage Change From Baseline in VM H-reflex Magnitude | H-reflex magnitude of vastus medialis. Lower values are considered better. The H-reflex is the amplitude of the monosynaptic spinal reflex, elicitied by electrical stimulation of the femoral nerve, normalized by the preceding M-wave. The M-wave is the amplitude of the muscle activity response to surface electrical stimulation of the femoral nerve. All muscle activity measured at the individual's vastus medialis of the stimulated limb. A value of 100% would mean no change in reflex magnitude, whereas a change of -20%, for instance, would mean a 20% drop in reflex magnitude over the 3 month training period. | Posted | Mean | Standard Error | percentage change in reflex size | 3 months |
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| 7 |
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| 7 |
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| 7 |
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