N/A
Completed N=33
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients
Source: ClinicalTrials.gov NCT00715520 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) — 1.01; 1.63; 1.29; .73 mV
Summary
The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) |
1.01; 1.63; 1.29; .73; 1.22; 1.08 | — |
| PRIMARY Aim 1: Mean Peak Acceleration of Wrist Extension Movements |
1.32; 1.33; 1.24; 1.24; 1.28; 1.29 | — |
| SECONDARY Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse |
.39; .66; .63; .69; .40; .54 | — |
| SECONDARY Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse |
1.33; 1.43; 1.51; 1.53; 1.44; 1.36 | — |
| SECONDARY Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency |
.67; .93; .94; 1.02; .71; 1.06 | — |
| SECONDARY Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency |
1.44; 1.36; 1.35; 1.33; 1.33; 1.43 | — |
| SECONDARY Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC) |
— | — |
| SECONDARY Aim 3: Mean Peak Acceleration of Wrist Extension Movements |
— | — |
Eligibility Criteria
Aims 1 and 2
Inclusion Criteria
- Normal neurological examination
- Ability to meet criteria of inclusion experiment
- Ability to give informed consent.
Exclusion Criteria
- History or neurological or psychiatric disease
- Abnormal MRI of brain
- Abnormal neuropsychological testing
- Intake of CNS active drugs
- History of seizure disorder
- History of migraine headaches
- History of anaphylaxis or allergic reactions
- Contraindication to TMS
Aim 3:
Inclusion Criteria
- Cerebral ischemic infarction more than 6 months prior to entering the study
- Single lesion as defined by MRI of the brain affecting the primary motor output system of the hand at a cortical (M1) level or subcortical level, or unilateral, and supratentorial in absence of history of a previous symptomatic stroke within 3 months of the current stroke
- Dense paresis of the hand for more than three days after cerebral infarction (MRC of 100 μV and an increase in MEP amplitude with increasing stimulus intensity (up to 100% of MSO) of at least 20% over MEP amplitude at MT
Exclusion Criteria
- History or neurological or psychiatric disease, including bipolar disorder
- Intake of CNS active drugs
- History of seizure disorder
- History of migraine headaches
- History of anaphylaxis or allergic reactions
- Contraindication to TMS
Data sourced from ClinicalTrials.gov (NCT00715520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.