Repetitive Transcranial Magnetic Stimulation in Spatial Attention After Stroke (NCT04080999) | Clinical Trial Compass
UnknownNot Applicable
Repetitive Transcranial Magnetic Stimulation in Spatial Attention After Stroke
Italy56 participantsStarted 2018-12-05
Plain-language summary
Randomized Controlled Trial (RCT) aiming at assessing the efficacy of a novel rehabilitation protocol, based on repetitive transcranial magnetic stimulation (r- TMS) in combination with a conventional cognitive treatment (CCT). The protocol will be statistically compared to the same CTT administered without the r-TMS in a sample of right-stroke patients (age between 18 and 80 years) with left hemispatial Neglect.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Diagnosis of ischemic stroke in the right middle cerebral artery or right intra-cerebral hemorrhagic stroke, confirmed by brain CT and / or brain MRI;
✓. Diagnosis of LHSN with a specific test (asymmetry score on Bells cancellation test \> 3\]);
✓. Intra-hospital rehabilitation setting (ordinary hospitalization or DH) or outpatient setting;
✓. Age between 18 and 80 years;
✓. Time between stroke onset and study recruitment three weeks to three months;
✓. Availability to provide informed consent to participation.
Exclusion criteria
✕. Clinical instability at recruitment (for example, fever, acute internist conditions, etc.);
✕. History of epilepsy and / or occurrence in the acute phase of at least one seizure crisis
✕. Presence of intracranial metallic implants;
✕. Presence of devices, which could be altered by r-TMS, such as pacemakers, ventricular-peritoneal derivations, Baclofen pump;
✕. Absence of a bone operculum following a neurosurgical operation of decompressive craniotomy;
✕. Presence of behavioral disturbances with inversion of the sleep-wake rhythm
What they're measuring
1
Change from Baseline: behavioral Inattention Test (BIT)
Timeframe: up to 21 days post baseline and up to 90 days follow-up