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Repetitive Transcranial Magnetic Stimulation in Traumatic Brain Injury (Smart trace)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573413
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Fabio La Porta
Francesco Di Gregorio
Roberto Piperno
Emanuela Casanova
Information provided by (Responsible Party):
Azienda Usl di Bologna

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 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.

Condition or disease Intervention/treatment Phase
Perceptual Disorders Traumatic Brain Injury Device: Inhibitory repetitive transcranial magnetic stimulation Device: Sham Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of TBI;
  2. Diagnosis of LHSN with specific assessment tests (line bisection test and / or star cancellation test);
  3. Intra-hospital rehabilitation setting (ordinary hospitalization or DH);
  4. Age between 18 and 80 years;
  5. Time after injury between three weeks and 1 year;
  6. Level of cognitive functioning (LCF ≥5 )
  7. Adequate language comprehension

Exclusion Criteria:

  1. Clinical instability at enrollment (for example, fever, acute internist conditions, etc.);
  2. Presence of epileptogenic alterations to the EEG and / or previous epileptic seizures;
  3. Presence of intracranial implants of metallic material;
  4. Presence of devices that could be altered by rTMS, such as pacemakers, ventriculo-peritoneal derivations, Baclofen pump;
  5. Acute neurosurgery, including decompressive craniotomy;
  6. Drugs conditioning the state of consciousness-vigilance such as benzodiazepines;
  7. Cortical blindness and / or visual agnosia;
  8. Concomitant psychiatric disorders and / or history of substance abuse;
  9. Post-traumatic agitation
  10. Post-traumatic complications (i.e. hydrocephalus)

Information from the National Library of Medicine

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


Contacts
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Contact: Francesco Di Gregorio, PhD 3290762585 francesco.digregorio@ausl.bologna.it

Locations
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Italy
Azienda Unità Sanitaria Locale di Bologna 40124, Bologna, Italy
Bologna, Italy, 40124
Contact: Francesco Di Gregorio, PhD    3290762585    francesco.digregorio@ausl.bologna.it   
Principal Investigator: Francesco Di Gregorio, Di Gregorio         
Sponsors and Collaborators
Azienda Usl di Bologna
Fabio La Porta
Francesco Di Gregorio
Roberto Piperno
Emanuela Casanova
Additional Information:
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Responsible Party: Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT04573413    
Other Study ID Numbers: SG-2018-12367527
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Usl di Bologna:
Electroenephalography
repetitive Transcranial magnetic stimulation
Hemispatial Neglect
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Perceptual Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations