NCT04573413

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

September 28, 2020

Last Update Submit

February 15, 2022

Conditions

Perceptual DisordersTraumatic Brain Injury

Keywords

Electroenephalographyrepetitive Transcranial magnetic stimulationHemispatial Neglect

Outcome Measures

Primary Outcomes (1)

  • visual-Attention Bias Index (vABI)

    Change from Baseline: visual-Attention Bias Index (vABI). Psychophysiological index of inter-hemispheric imbalance in a visual-spatial attention task

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

Secondary Outcomes (8)

  • behavioral Inattention Test (BIT)

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

  • catherine Bergegò Scale (CBS)

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

  • test of Attention Performance (TAP/TEA)

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

  • functional independence measure (FIM)

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

  • Motricity Index (MI)

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

  • +3 more secondary outcomes

Study Arms (2)

r-TMS group

EXPERIMENTAL

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

SHAM group

SHAM COMPARATOR

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

Interventions

Inhibitory repetitive transcranial magnetic stimulationDEVICE

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

r-TMS group
Sham GroupDEVICE

Sham stimulation and Visual scanning training Intervention: Device: SHAM

SHAM group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Unità Sanitaria Locale di Bologna 40124, Bologna, Italy

Bologna, 40124, Italy

RECRUITING

Related Publications (1)

  • Di Gregorio F, La Porta F, Lullini G, Casanova E, Petrone V, Simoncini L, Ferrucci E, Piperno R. Efficacy of Repetitive Transcranial Magnetic Stimulation Combined With Visual Scanning Treatment on Cognitive-Behavioral Symptoms of Unilateral Spatial Neglect in Patients With Traumatic Brain Injury: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jul 14;12:702649. doi: 10.3389/fneur.2021.702649. eCollection 2021.

    PMID: 34335455DERIVED

Related Links

MeSH Terms

Conditions

Perceptual DisordersBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Francesco Di Gregorio, PhD

CONTACT

3290762585francesco.digregorio@ausl.bologna.it

Study Design

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

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

March 30, 2021

Primary Completion

January 30, 2023

Study Completion

March 30, 2023

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)