Repetitive Transcranial Magnetic Stimulation in Traumatic Brain Injury (NCT04573413) | Clinical Trial Compass
UnknownNot Applicable
Repetitive Transcranial Magnetic Stimulation in Traumatic Brain Injury
Italy28 participantsStarted 2021-03-30
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 traumatic brain injury patients (age between 18 and 80 years) with left hemispatial Neglect.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of TBI;
✓. Diagnosis of LHSN with specific assessment tests (line bisection test and / or star cancellation test);
✓. Intra-hospital rehabilitation setting (ordinary hospitalization or DH);
✓. Age between 18 and 80 years;
✓. Time after injury between three weeks and 1 year;
✓. Level of cognitive functioning (LCF ≥5 )
✓. Adequate language comprehension
Exclusion criteria
✕. Clinical instability at enrollment (for example, fever, acute internist conditions, etc.);
✕. Presence of epileptogenic alterations to the EEG and / or previous epileptic seizures;
✕. Presence of intracranial implants of metallic material;
✕. Presence of devices that could be altered by rTMS, such as pacemakers, ventriculo-peritoneal derivations, Baclofen pump;
✕. Acute neurosurgery, including decompressive craniotomy;
✕. Drugs conditioning the state of consciousness-vigilance such as benzodiazepines;
✕. Cortical blindness and / or visual agnosia;
What they're measuring
1
visual-Attention Bias Index (vABI)
Timeframe: up to 21 days post baseline and up to 90 days follow-up