MedTrace Logo

Repetitive Transcranial Magnetic Stimulation in Spatial Attention After Stroke

NCT04080999 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-02-16

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Emanuela Casanova

    collaborator UNKNOWN

  • Francesco Di Gregorio

    collaborator UNKNOWN

  • Fabio La Porta

    collaborator UNKNOWN

  • Roberto Piperno

    collaborator UNKNOWN

  • Azienda Usl di Bologna

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080999 on ClinicalTrials.gov