Repetitive Transcranial Magnetic Stimulation in Traumatic Brain Injury (Smart trace)
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|ClinicalTrials.gov Identifier: NCT04573413|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Perceptual Disorders Traumatic Brain Injury||Device: Inhibitory repetitive transcranial magnetic stimulation Device: Sham Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Repetitive Transcranial Magnetic Stimulation (r-TMS) Combined With Visual Scanning Treatment on Cognitive-behavioral Symptoms of Unilateral Spatial Neglect in Patients With Traumatic Brain Injury: a Randomized Clinical Trial|
|Estimated Study Start Date :||October 30, 2020|
|Estimated Primary Completion Date :||January 30, 2023|
|Estimated Study Completion Date :||March 30, 2023|
Experimental: r-TMS 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.
Device: Inhibitory repetitive transcranial magnetic stimulation
r-TMS Parameters: International 10/20 system for the location of the target area (left parietal cortex) 60% Power Frequency: 1 Hz 90 pulse trains with 10 pulses each (total 900 stimuli), resulted in a total stimulation period of 15 minutes.
Visual Scanning Visual-spatial training; Reading and copying training; Copying of line drawings on a dot matrix. Barrage
Sham Comparator: SHAM group
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.
Device: Sham Group
Sham stimulation and Visual scanning training Intervention: Device: SHAM
- visual-Attention Bias Index (vABI) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]Change from Baseline: visual-Attention Bias Index (vABI). Psychophysiological index of inter-hemispheric imbalance in a visual-spatial attention task
- behavioral Inattention Test (BIT) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]1. Change from Baseline: behavioral Inattention Test (BIT). A battery for the assessment of cognitive and behavioral symptoms in LHSN
- catherine Bergegò Scale (CBS) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]2. Change from Baseline: catherine Bergegò Scale (CBS). A battery for the assessment of LHSN symptoms in the activity of daily living.
- test of Attention Performance (TAP/TEA) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]3. Change from Baseline: test of Attention Performance (TAP/TEA). Two subtest will be executed "alertness" and "Visual field/Neglect" to assess attentive functions
- functional independence measure (FIM) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]4. Change from Baseline: functional independence measure (FIM). The motor subscale will be executed to assess motor independence
- Motricity Index (MI) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]5. Change from Baseline: Motricity Index (MI). A test to assess motor impairment in stroke patients
- Trunk Control Test (TCT) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]6. Change from Baseline: Trunk Control Test (TCT). A test to assess the ability to control the trunk after stroke.
- Inter Hemispheric transmission Time (IHTT) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]7. Change from Baseline: Inter Hemispheric transmission Time (IHTT). Psychophysiological index of inter-hemispheric transmission time.
- Level of Cognitive Functioning (LCF) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]8. Change from Baseline: Level of Cognitive Functioning (LCF). A test to assess general cognitive functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573413
|Contact: Francesco Di Gregorio, PhDfirstname.lastname@example.org|
|Azienda Unità Sanitaria Locale di Bologna 40124, Bologna, Italy|
|Bologna, Italy, 40124|
|Contact: Francesco Di Gregorio, PhD 3290762585 email@example.com|
|Principal Investigator: Francesco Di Gregorio, Di Gregorio|