Repetitive Transcranial Magnetic Stimulation in Traumatic Brain Injury (Smart trace)
Perceptual Disorders, Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Perceptual Disorders focused on measuring Electroenephalography, repetitive Transcranial magnetic stimulation, Hemispatial Neglect
Eligibility Criteria
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;
- Concomitant psychiatric disorders and / or history of substance abuse;
- Post-traumatic agitation
- Post-traumatic complications (i.e. hydrocephalus)
Sites / Locations
- Azienda Unità Sanitaria Locale di Bologna 40124, Bologna, ItalyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
r-TMS group
SHAM group
The interventions have a total administration time of 75 minutes per day. For rTMS stimulation, the coil will be positioned tangentially on the target area. Each rTMS session will last 15 minutes and will be administered every other day (e.g. Monday-Wednesday-Friday, Monday-Wednesday-Friday, Monday). The CCT (i.e. visual scanning treatment) involves the presence of a therapist, who administers various visual scanning tasks, used to increase patient's awareness and to teach strategies to improve spatial exploration abilities.Trainings include three increasing levels of difficulty (9 possible combinations). Each level of difficulty will be exercised until the patient reaches a level of accuracy of 75%. The CCT will be carried out in 50 minutes sessions for 5 days a week within 15 days (11 sessions in total). On the days when the rTMS is also administered, the administration of the CCT will immediately follow the brain stimulation.
SHAM Stimulation and Visual Scanning training. In the control group, the coil of the r-TMS will be positioned at 90° on the target area, thus no specific cortical modulation will be implemented (SHAM stimulation). For the SHAM group, the CCT protocol will be administered with the same modalities and time frame as detailed for the experimental group.