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
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: r-TMS Device: SHAM||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
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 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.
- 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
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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
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
|Contact: Emanuela Casanova, Mdfirstname.lastname@example.org|
|Contact: Francesco Di Gregorio, PhDemail@example.com|
|Bologna, Bo, Italy, 40133|
|Contact: Francesco Di Gregorio, PhD 3290762585 firstname.lastname@example.org|
|Azienda Unità Sanitaria Locale||Recruiting|
|Bologna, Italy, 40100|