Trial · NCT00715520
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients
NCT00715520, Not applicable, Completed, Emory University; results first posted 2017-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neurobiological Principles Applied to the Rehabilitation of Stroke Patients. Trials, record NCT00715520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00715520
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neurobiological Principles Applied to the Rehabilitation of Stroke Patients
- NCT number
- NCT00715520
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 33 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Stroke
- Interventions
Transcranial Magnetic Stimulation (TMS), Carbidopa-Levodopa, Methylphenidate, Amphetamine Sulfate, Placebo, Sham Transcranial Magnetic Stimulation (TMS), Transcranial Magnetic Stimulation (TMS) Training
- First posted
- 2008-07-15
- Last updated
- 2017-10-16
- Results first posted
- 2017-10-16
- Limitations and caveats
Target enrollment for aim 3 was not me due to difficulty identifying participants that met the inclusion criteria. Therefore the study team did not have a sufficient sample size to complete any data analysis for this aim.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning. |
| Primary | Aim 1: Mean Peak Acceleration of Wrist Extension Movements | Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. |
| Secondary | Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning. |
| Secondary | Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. |
| Secondary | Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. |
| Secondary | Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. |
| Secondary | Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning. |
| Secondary | Aim 3: Mean Peak Acceleration of Wrist Extension Movements | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Analysis was completed in Aim 1 participants per protocol for the placebo condition. One subject was not included in the analysis due to corrupt data. | mV | MEAN |
| PRIMARY | Aim 1: Mean Peak Acceleration of Wrist Extension Movements | Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Analysis was completed in Aim 1 participants per protocol. One subject was not included in the analysis due to corrupt data. | g | MEAN |
| SECONDARY | Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Analysis was completed in Aim 2 participants per protocol. | millivolts | MEAN |
| SECONDARY | Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Analysis was completed in Aim 2 participants per protocol. | g | MEAN |
| SECONDARY | Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Analysis was completed in Aim 2 participants per protocol. | millivolts | MEAN |
| SECONDARY | Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | Analysis was completed in Aim 2 participants per protocol. | g | MEAN |
| SECONDARY | Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | No sufficient data collected. | ||
| SECONDARY | Aim 3: Mean Peak Acceleration of Wrist Extension Movements | Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) | No sufficient data collected. |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Baseline Placebo - MEPmax | 1.01 | Standard Error .13 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Post-Training 1 Placebo - MEPmax | 1.63 | Standard Error .33 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Post-Training 2 Placebo - MEPmax | 1.29 | Standard Error .05 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Baseline - Amphetamine Sulfate - MEPmax | .73 | Standard Error .10 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Post-Training 1 Ampletamine Sulfate - MEPmax | 1.22 | Standard Error .26 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Post-Training 2 Amphetamine Sulfate - MEPmax | 1.08 | Standard Error .04 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Baseline Methylphenidate - MEPmax | 1.04 | Standard Error .13 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Post-Training 1 Methylphenidate - MEPmax | 1.10 | Standard Error .12 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Post-Training 2 Methylphenidate - MEPmax | 1.22 | Standard Error .06 | mV |
| Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) | Aim 1 | Baseline Carbidopa-Levodopa - MEPmax | 1.81 | Standard Error .62 | mV |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aim 1 | 20 | |
| Overall Study | STARTED | Aim 2 | 10 | |
| Overall Study | STARTED | Aim 3 | 3 | |
| Overall Study | COMPLETED | Aim 1 | 10 | |
| Overall Study | COMPLETED | Aim 2 | 9 | |
| Overall Study | COMPLETED | Aim 3 | 1 | |
| Overall Study | NOT COMPLETED | Aim 1 | 10 | |
| Overall Study | NOT COMPLETED | Aim 2 | 1 | |
| Overall Study | NOT COMPLETED | Aim 3 | 2 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertio | Ear and labyrinth disorders | Aim 1 | 1 | 10 | 1 |
| other | Vertio | Ear and labyrinth disorders | Aim 2 | 0 | 9 | 0 |
| other | Vertio | Ear and labyrinth disorders | Aim 3 | 0 | 1 | 0 |
| other | Increased Blood Pressure | Vascular disorders | Aim 1 | 1 | 10 | 1 |
| other | Increased Blood Pressure | Vascular disorders | Aim 2 | 0 | 9 | 0 |
| other | Increased Blood Pressure | Vascular disorders | Aim 3 | 0 | 1 | 0 |
| other | Dizziness | Nervous system disorders | Aim 1 | 3 | 10 | 3 |
| other | Dizziness | Nervous system disorders | Aim 2 | 0 | 9 | 0 |
| other | Dizziness | Nervous system disorders | Aim 3 | 0 | 1 | 0 |
| other | Dry Mouth | Gastrointestinal disorders | Aim 1 | 1 | 10 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aim 1 | 0 | 10 |
| Total, all-cause mortality | Aim 2 | 0 | 9 |
| Total, all-cause mortality | Aim 3 | 0 | 1 |
| Total, other adverse events | Aim 1 | 5 | 10 |
| Total, other adverse events | Aim 2 | 0 | 9 |
| Total, other adverse events | Aim 3 | 1 | 1 |
| Total, serious adverse events | Aim 1 | 0 | 10 |
| Total, serious adverse events | Aim 2 | 0 | 9 |
| Total, serious adverse events | Aim 3 | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS060830 | Neurobiological principles applied to the rehabilitation of stroke patients | BUETEFISCH, CATHRIN M | EMORY UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2007 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00715520
GET https://conductscience.org/api/trials/v1/NCT00715520/results?page=2