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Effects of two types of associated brain stimulation to improve unilateral spatial neglect after stroke

Effect of Transcranial Magnetic Stimulation by Theta Burst Modality as a Priming Effect to Transcranial Direct Current Stimulation in Unilateral Spatial Neglect after Stroke: TITAN TRIAL - TITAN TRIAL effect of transcranial magnetic sTImulation by theta burst modality as a priming effect to TrANscranial direct current stimulation in unilateral spatial neglect after stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2typh66
Enrollment
Unknown
Registered
2023-10-24
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

This is a multicenter, randomized, placebo-controlled, double-blind clinical trial. The individuals will be allocated to three groups, with a random distribution program generated by a computer, using
(N=17). Group 2 – Conventional Group (CG): Transcranial direct current stimulation of the anodic type in the right parietal lobe, anode was placed on P4, and the cathode was placed on the left supraor
(N=17). Group 3 - Sham Group (GS): Transcranial sham direct current stimulation, the stimulator was turned on and the current intensity was gradually increased for 30 s and decreased for 30 s, with sh
E02.621.820
E02.331.750

Sponsors

Departamento de Clinica Médica
Lead Sponsor
Departamento de Clinica Médica
Collaborator

Eligibility

Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes, aged 18 to 85 years, with a diagnosis of ischemic stroke in the subacute phase (7 days to 3 months from the onset of symptoms, due to lesions of the right virus, confirmed by tomography CT and or magnetic resonance imaging (MRI) and unilateral spatial neglect diagnosed by checking less than 129 on the Behavior Intention Test - BIT

Exclusion criteria

Exclusion criteria: Individuals with any metal in the head segment, skin lesions in the electrode placement area, clinical instability, severe cognitive impairment, global aphasia, visual disturbances prior to stroke, hemorrhagic stroke, previous Rankin bigger then 1, bilateral lesions, pacemaker, epilepsy, severe CHF or unstable conditions that may pose a risk to the participant, concurrent diagnosis of rapidly deteriorating illness (eg, terminal cancer), participating in studies involving medications or other interventions, pregnancy, or other associated neurological conditions

Design outcomes

Primary

MeasureTime frame
Decrease the degree of unilateral spatial neglect after treatment verified by Behavior Inattention Test (BIT), from finding a variation of at least 15% in the pre and post intervention measurements.

Secondary

MeasureTime frame
Decrease the degree of unilateral spatial neglect after treatment verified by Catherine Bergego scale, from finding a variation of at least 15% in the pre and post intervention measurements.;Increasing the degree of autonomy observed with the Barthel index, from the finding of a change of at least 15% in pre and post intervention measurements.;Increasing the functional capacity observed with the modified Rankin scale, from the finding of a change of at least 15% in pre and post intervention measurements.;Decrease in frailty observed with the PRISMA-7 scale, based on the verification of a change of at least 15% in pre- and post-intervention measurements.;Increase in the degree of quality of life verified through the European scale of quality of life, based on the verification of a variation of at least 15% in the pre and post intervention measurements.;Increase in reported self-efficacy verified using The Stroke Self-Efficacy Questionnaire Brazil scale, based on the verification of a variation of at least 15% in pre- and post-intervention measurements.

Countries

Brazil

Contacts

Public ContactLuana Miranda

Hospital das clinicas da faculdade de medicina de Botucatu - HCFMB Unesp

la.miranda@unesp.br+55-014-996449503

Outcome results

None listed

Source: REBEC (via WHO ICTRP)