N/A
N=22
Combined Brain and Peripheral Nerve Stimulation for Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01907737 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Active Range of Motion of Wrist Extension in the Paretic Side — 37.8; 38; 37.2; 38 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active tDCS (Other); Active PNS (Other); Sham tDCS (Other); Sham PNS (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Active Range of Motion of Wrist Extension in the Paretic Side |
37.8; 38; 37.2; 38; 36.5; 36.2 | — |
Summary
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. We will non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve stimulation, will enhance effects of motor training to a greater extent than brain stimulation alone, peripheral stimulation alone, or no stimulation.
Eligibility Criteria
Inclusion Criteria
- Age, 18 years or older;
- First-ever, ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function;
- Ability to provide written Informed Consent (patient or legal representative);
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion Criteria
- Lack of ability to voluntarily activate any active range of wrist extension;
- Anesthesia of the paretic hand;
- Stroke lesions affecting entirely the hand knob area of the motor cortex120;
- Stroke lesions affecting the cerebellum or the brain stem;
- Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of >3 on the Modified Ashworth Spasticity Scale;
- Active joint deformity;
- Uncontrolled medical problems such as end-stage cancer or renal disease;
- Pregnancy;
- Seizures;
- Pacemakers;
- Other neurological disorders such as Parkinson's disease;
- Psychiatric illness including severe depression;
- Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent. A score in the Minimental State Examination lower than 23/30 points will be used for patients with higher than 1 year of education, and a score lower than 19/30 will be used for patients with 1 year of education or less.
Data sourced from ClinicalTrials.gov (NCT01907737). 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.