N/A
N=3
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Hemiparesis · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02132520 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI — 0.71; 0.72; -0.25; 0.81 Laterality index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS (Device); BCI Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI |
0.71; 0.72; -0.25; 0.81; 1; 0.80 | — |
| SECONDARY Changes in Hand Motor Function as Measured by the Box and Block Test |
26.0; 2.67; 32.3; 1.66; 39.4; 2.84 | — |
| SECONDARY Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test |
0.005; -0.028; 0.008; -0.011; 0.009; -0.008 | — |
| SECONDARY Changes in Inter-hemispheric Inhibition |
1.28; 0.64; 1.26; 0.42; 0.90; 1.41 | — |
Summary
The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke.
The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.
Eligibility Criteria
Inclusion Criteria
- 18-70 years of age
- Cortical or subcortical stroke with isolated unilateral motor paresis
- At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician
- Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension
- Able to ambulate at least 50 feet with minimal stand-by assistance
- Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66
- Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63
- Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30
- Must have an ipsilesional motor-evoked potential (MEP) in response to TMS
- Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care
- Must be able to communicate clearly in English
- Must be able to provide consent in writing.
Exclusion Criteria
- Personal history of epilepsy or seizures within the past 2 years
- Previous surgical procedure to the spinal cord
- Any MRI incompatible devices
- Pregnancy
- Claustrophobia
- Breathing disorder
- Hearing problems or ringing in the ears
- Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
- Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
Data sourced from ClinicalTrials.gov (NCT02132520). 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.