Table.
Recommended Criteria for Enrolling Adults With Acute Stroke in Trials with Repetitive Transcranial Magnetic Stimulation (rTMS) to Promote Motor Recovery
Criteria | Recommendation | Rationale |
---|---|---|
Age | Include ≥ 18 y | Inclusivity |
Stroke type | Include ischemic and hemorrhagic. | Hemorrhagic has higher risk for seizure81 but not observed with rTMS.82-85 |
Include single and recurrent. | Recurrent silent strokes occur more frequently than recognized80 and are difficult to avoid. | |
Stroke location | Include unilateral and bilateral. | Bilateral confounds general analysis but can be managed with introspective analysis. |
Include cortical, subcortical, or brainstem. | Variation in location unavoidably confounds general analysis but can be managed with introspective analysis. | |
Stroke duration | Exclude poststroke onset <5 days and >30 days. | Immediately post stroke could possibly impinge on excitotoxicity cascade. Waiting 5 days avoids the period when seizures are most common in hemorrhagic stroke.86 Waiting >30 days could exclude possible advantages of early-stage recovery mechanisms. |
Motor function | Exclude no visible impairment. Include both no and partial active movement. | No impairment cannot benefit. |
Both no and partial active movement could benefit and be stratified for analysis. | ||
Cognition | Include impaired cognition, all aphasias, and neglect. | Inclusivity. Consent can be obtained from surrogate. These patients have received rTMS in past.56-61 |
Length of stay | Exclude if anticipated stay is less than total days for treatment and testing. | Early discharge would eliminate patient's data. Efforts to -increase length of stay must occur. |
Seizure history | Exclude seizures within past 2 y (even if on antiseizure -medication). | Cortical stability needs to be affirmed before introducing -intervention with seizure risk. |
Metal in head | Exclude most metals. | Risk of disrupting metal with magnetic stimulation. |
Include dental metal. | ||
Indwelling medical device | Exclude until specific indwelling device is tested and shown to be unaffected. | Possible disruption of device. Risk of rTMS in presence of cardiac pacemaker and other devices must be determined rather than assumed. |
Pregnancy | Exclude. | Unknown risks to fetus. |
Depression | Exclude score >10 on Beck Depression Inventory.66 | Depression associated with poor recovery from stroke.64 |
Medications | Exclude tricyclic antidepressants or neuroleptics. | Increased risk of seizures or other brain dysfunction. |