N/A
Completed N=20
Can rTMS Enhance Somatosensory Recovery After Stroke?
Source: ClinicalTrials.gov NCT02811913 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Change From Baseline in Two-point Discrimination — -0.7; -0.5; -0.1; -1.7 mm
Summary
Stroke affects over 795,000 Americans every year and has an enormous impact on the well-being of American Veterans with 6,000 new stroke admissions every year. Many of these stroke survivors are living with disabilities that limit their everyday function. One of the major consequences of stroke is loss of sensation which manifests as inability to perceive touch, temperature, pain or limb movement. Lack of sensation hinders full functional recovery. Current treatments for sensory loss produce only limited improvements and do not achieve full recovery. Therefore, it is critical to develop new therapies to re-train sensory function. The investigators propose to evaluate a novel non-invasive brain stimulation treatment called repetitive Transcranial Magnetic Stimulation (rTMS). The effects of this technique on motor deficits following stroke have been studied, however rTMS for the treatment of sensory loss has not been examined to date. The investigators' study will examine for the first time if rTMS of a sensory brain region can improve sensory function in chronic stroke survivors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Two-point Discrimination |
-0.7; -0.5; -0.1; -1.7; -0.3; 0.1 | — |
| PRIMARY Change From Baseline in N20 Somatosensory Evoked Potential(SSEP) Peak Latency |
-1.1; 0.1; 0.7; 0.1; -1.8; 1.2 | — |
Eligibility Criteria
Inclusion Criteria
- Medically stable at least 6 months after first ever stroke.
- Sufficient endurance to participate in the study.
- Cognition sufficiently intact to give valid informed consent to participate.
- Age > 18years.
- Ability to follow 2 stage commands.
- Impaired but not absent ability to feel touch, vibration and movement of the affected arm.
Exclusion Criteria
- Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
- Any psychiatric diagnosis or active psychological condition.
- History of substance abuse within the last 6 months
- More than one ischemic stroke or stroke affecting both sides.
- Claustrophobia, or inability to operate the MRI patient call button.
- Pregnancy or pregnancy planning during the study period.
- Lower motor neuron damage or radiculopathy
- Contraindications for rTMS according to the TMS-use guidelines (Rossi et al 2009).
- Inability to understand English.
- Significant neglect for those with left-sided deficits.
Data sourced from ClinicalTrials.gov (NCT02811913). 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.