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Trial record 12 of 44 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

Repetitive Transcranial Magnetic Stimulation in Spatial Attention After Stroke (r-TMS)

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ClinicalTrials.gov Identifier: NCT04080999
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
Emanuela Casanova
Francesco Di Gregorio
Fabio La Porta
Roberto Piperno
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 right-stroke patients (age between 18 and 80 years) with left hemispatial Neglect.

Condition or disease Intervention/treatment Phase
Stroke Device: r-TMS Device: SHAM Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Transcranial Magnetic Stimulation (r-TMS) Combined With Conventional Cognitive Treatment on Cognitive-behavioral Symptoms of Left Hemispatial Neglect in Right-stroke Patients Within Three Months Post-onset Compared to Conventional Cognitive Treatment Only: a Randomized Controlled Trial
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 5, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: r-TMS Group

r-TMS Parameters International 10/20 system for the location of the target area (non-lesioned 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

Device: r-TMS
The interventions have a total administration time of 75 minutes per day.For TMS stimulation, the coil will be positioned tangentially on the target area. Each r-TMS session will last 15 minutes and will be administered every other day (e.g. Monday-Wednesday-Friday, Monday-Wednesday-Friday, Monday). The 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 (Pizzamiglio et al.,1992).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 r-TMS is also administered, the administration of the CCT will immediately follow the brain stimulation.

Sham Comparator: Sham Group
Sham stimulation and Visual scanning training
Device: SHAM
Device: 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 intervention group.




Primary Outcome Measures :
  1. Change from Baseline: behavioral Inattention Test (BIT) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    A battery for the assessment of cognitive and behavioral symptoms in LHSN


Secondary Outcome Measures :
  1. Change from Baseline: catherine Bergegò Scale (CBS) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    A battery for the assessment of LHSN symptoms in the activity of daily living.

  2. Change from Baseline: test of Attention Performance (TAP/TEA) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    two subtest will be executed "alertness" and "Visual field/Neglect" to assess attentive functions

  3. Change from Baseline: functional independence measure (FIM) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    The motor subscale will be executed to assess motor independence

  4. Change from Baseline: Motricity Index (MI) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    A test to assess motor impairment in stroke patients.

  5. Change from Baseline: Trunk Control Test (TCT) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    A test to assess the ability to control the trunk after stroke.

  6. Change from Baseline: Inter Hemispheric transmission Time (IHTT) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    Psychophysiological index of inter-hemispheric transmission.

  7. Change from Baseline: visual-Attention Bias Index (vABI) [ Time Frame: up to 21 days post baseline and up to 90 days follow-up ]
    Psychophysiological index of inter-hemispheric imbalance in a visual-spatial attention task



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 ischemic stroke in the right middle cerebral artery or right intra-cerebral hemorrhagic stroke, confirmed by brain CT and / or brain MRI;
  2. Diagnosis of LHSN with a specific test (asymmetry score on Bells cancellation test > 3]);
  3. Intra-hospital rehabilitation setting (ordinary hospitalization or DH) or outpatient setting;
  4. Age between 18 and 80 years;
  5. Time between stroke onset and study recruitment three weeks to three months;
  6. Availability to provide informed consent to participation.

Exclusion criteria

  1. Clinical instability at recruitment (for example, fever, acute internist conditions, etc.);
  2. History of epilepsy and / or occurrence in the acute phase of at least one seizure crisis
  3. Presence of intracranial metallic implants;
  4. Presence of devices, which could be altered by r-TMS, such as pacemakers, ventricular-peritoneal derivations, Baclofen pump;
  5. Absence of a bone operculum following a neurosurgical operation of decompressive craniotomy;
  6. Presence of behavioral disturbances with inversion of the sleep-wake rhythm
  7. Mono- or bilateral occipital lesions documented on CT and / or history of cortical blindness or visual agnosia;
  8. Concomitant psychiatric disorders and / or history of substance abuse;
  9. State of pregnancy
  10. Inability to execute the following simple order: "Take the pen instead of the key and put it on the sheet"
  11. Severe acoustic deficit not corrected by the use of a hearing aid
  12. Severe reduction of the visus despite the use of eyeglasses
  13. Positive anamnesis of previous cognitive decline

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): NCT04080999


Contacts
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Contact: Emanuela Casanova, Md 3398999147 e.casanova@ausl.bologna.it
Contact: Francesco Di Gregorio, PhD 3290762585 francesco.digregorio@ku.de

Locations
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Italy
Ospedale Maggiore Recruiting
Bologna, Bo, Italy, 40133
Contact: Francesco Di Gregorio, PhD    3290762585    francesco.digregorio86@gmail.com   
Azienda Unità Sanitaria Locale Recruiting
Bologna, Italy, 40100
Sponsors and Collaborators
Azienda Usl di Bologna
Emanuela Casanova
Francesco Di Gregorio
Fabio La Porta
Roberto Piperno

Additional Information:
Azouvi, P., Jacquin-Courtois, S., & Luauté, J. (2016). Rehabilitation of unilateral neglect: Evidence-based medicine. Annals of Physical and Rehabilitation Medicine.  This link exits the ClinicalTrials.gov site Barnett, K. J., & Corballis, M. C. (2005). Speeded right-to-left information transfer: The result of speeded transmission in right-hemisphere axons? Neuroscience Letters, 380(1-2), 88-92.  This link exits the ClinicalTrials.gov site Cermak, S. A., & Hausser, J. (1989). The behavioral inattention test for unilateral visual neglect: A critical review. Physical and Occupational Therapy in Geriatrics, 7(3), 43-53.  This link exits the ClinicalTrials.gov site Corbetta M, Kincade MJ, Lewis C, Snyder AZ, & A., S. (2005). Neural basis and recovery of spatial attention deficits in spatial neglect. Nat Neurosci., 8(11), 1603-1610  This link exits the ClinicalTrials.gov site Deouell, L. Y., Bentin, S., Soroker, N., & Deouell, L. Y. (2000). Electrophysiological evidence for an early (pre-attentive) information processing deficit in patients with right hemisphere damage and unilateral neglect. Brain, 123(2), 353-365  This link exits the ClinicalTrials.gov site Di Russo, F., Aprile, T., Spitoni, G., & Spinelli, D. (2008). Impaired visual processing of contralesional stimuli in neglect patients: A visual-evoked potential study. Brain, 131(3), 842-854.  This link exits the ClinicalTrials.gov site Di Russo, F., Bozzacchi, C., Matano, A., & Spinelli, D. (2013). Hemispheric differences in VEPs to lateralised stimuli are a marker of recovery from neglect. Cortex, 49(4), 931-939  This link exits the ClinicalTrials.gov site Dietz, M. Et:al., (2014). Effective connectivity reveals right-hemisphere dominance in audiospatial perception: implications for models of spatial neglect. The Journal of Neuroscience : The O  This link exits the ClinicalTrials.gov site Jacquin-courtois, S. (2015). ScienceDirect Hemi-spatial neglect rehabilitation using non-invasive brain stimulation : Or how to modulate the disconnection syndrome ? Annals of Physical and Rehabilitation Medicine, 58(4), 251-258.  This link exits the ClinicalTrials.gov site Müri, R. M., Cazzoli, D., Nef, T., Urs, P., & Nyffeler, T. (2013). Non-invasive brain stimulation in neglect rehabilitation : an update, 7(June), 1-10.  This link exits the ClinicalTrials.gov site Oliveri, M. (2011). Brain stimulation procedures for treatment of contralesional spatial neglect. Restorative Neurology and Neuroscience.  This link exits the ClinicalTrials.gov site Pizzamiglio, L. Et:al., (1992). Cognitive rehabilitation of the hemineglect disorder in chronic patients with unilateral right brain damage. Journal of Clinical and Experimental Neuropsychol  This link exits the ClinicalTrials.gov site Sozzi, M., Balconi, M., Arangio, R., Pisani, L., & Mariani, C. (2012). Top-down strategy in rehabilitation of spatial neglect: How about age effect? Cognitive Processing, 13(1 SUPPL), 339-342  This link exits the ClinicalTrials.gov site

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Responsible Party: Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT04080999     History of Changes
Other Study ID Numbers: 17075
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participants data for all primary and secondary outcome measures will be made avalaible
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Azienda Usl di Bologna:
r-TMS
Hemispatial Neglect
Visual Scanning
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases