Status:
UNKNOWN
Repetitive Transcranial Magnetic Stimulation in Spatial Attention After Stroke
Lead Sponsor:
Azienda Usl di Bologna
Collaborating Sponsors:
Emanuela Casanova
Francesco Di Gregorio
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
BACKGROUND: A frequent and disabling impairment in persons who suffered acquired brain injury after stroke is left hemispatial neglect (LHSN). LHSN is a spatial attentive syndrome characterized by a r...
Eligibility Criteria
Inclusion
- 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
- Mono- or bilateral occipital lesions documented on CT and / or history of cortical blindness or visual agnosia;
- Concomitant psychiatric disorders and / or history of substance abuse;
- State of pregnancy
- Inability to execute the following simple order: "Take the pen instead of the key and put it on the sheet"
- Severe acoustic deficit not corrected by the use of a hearing aid
- Severe reduction of the visus despite the use of eyeglasses
- Positive anamnesis of previous cognitive decline
Exclusion
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04080999
Start Date
December 5 2018
End Date
December 31 2022
Last Update
February 16 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Maggiore
Bologna, Bo, Italy, 40133
2
Azienda Unità Sanitaria Locale
Bologna, Italy, 40100