Repetitive Transcranial Magnetic Stimulation in Spatial Attention After Stroke

NCT04080999 | Unknown

• 1 other identifier: 17075
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

r-TMS; Hemispatial Neglect; Visual Scanning

Outcome Measures

Primary Outcomes (1)

• Change from Baseline: behavioral Inattention Test (BIT)

  A battery for the assessment of cognitive and behavioral symptoms in LHSN

  up to 21 days post baseline and up to 90 days follow-up

Secondary Outcomes (7)

• Change from Baseline: catherine Bergegò Scale (CBS)

  up to 21 days post baseline and up to 90 days follow-up

• Change from Baseline: test of Attention Performance (TAP/TEA)

  up to 21 days post baseline and up to 90 days follow-up

• Change from Baseline: functional independence measure (FIM)

  up to 21 days post baseline and up to 90 days follow-up

• Change from Baseline: Motricity Index (MI)

  up to 21 days post baseline and up to 90 days follow-up

• Change from Baseline: Trunk Control Test (TCT)

  up to 21 days post baseline and up to 90 days follow-up

Study Arms (2)

r-TMS Group

EXPERIMENTAL

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

Sham Group

SHAM COMPARATOR

Sham stimulation and Visual scanning training

Device: SHAM

Interventions

r-TMS DEVICE

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.

r-TMS Group

SHAM DEVICE

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.

Sham Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead
• Emanuela Casanova: collaborator
• Francesco Di Gregorio: collaborator
• Fabio La Porta: collaborator
• Roberto Piperno: collaborator

Study Sites (2)

Ospedale Maggiore

Bologna, Bo, 40133, Italy

RECRUITING

Azienda Unità Sanitaria Locale

Bologna, 40100, Italy

RECRUITING

Related Publications (2)

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

  PMID: 34196963 DERIVED

• Di Gregorio F, La Porta F, Casanova E, Magni E, Bonora R, Ercolino MG, Petrone V, Leo MR, Piperno R. Efficacy of repetitive transcranial magnetic stimulation combined with visual scanning treatment on cognitive and behavioral symptoms of left hemispatial neglect in right hemispheric stroke patients: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):24. doi: 10.1186/s13063-020-04943-6.

  PMID: 33407787 DERIVED

Related Links

• Azouvi, P., Jacquin-Courtois, S., \& Luauté, J. (2016). Rehabilitation of unilateral neglect: Evidence-based medicine. Annals of Physical and Rehabilitation Medicine.
• 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.
• 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
• 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
• 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
• 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.
• 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.
• Oliveri, M. (2011). Brain stimulation procedures for treatment of contralesional spatial neglect. Restorative Neurology and Neuroscience.
• 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

MeSH Terms

Conditions

Stroke; Perceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emanuela Casanova, Md

CONTACT

3398999147; e.casanova@ausl.bologna.it

Francesco Di Gregorio, PhD

CONTACT

3290762585; francesco.digregorio@ku.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: September 6, 2019
• Study Start: December 5, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

IT (2)