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Comparative study of the effect of the intervention of real Transcranial Led Therapy and placebo, on anxiety and depression with patients with TBI.

Prospective randomized, double-blind, placebo-controlled study of the effects of the Transcranial Led Therapy Intervention (TLT) on anxiety and depression in patients with traumatic brain injury (TBI).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8jcwjp
Enrollment
Unknown
Registered
2020-06-25
Start date
2019-01-01
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

Craniocerebral Trauma, anxiety, depression, Pathological conditions, signs and symptoms, Low-Level Light Therapy

Interventions

The intervention will be carried out in two groups: Group A: LED stimulation protocol with active helmet. Group B: similar protocol of LED stimulation with a non-active helmet (or sham). The administr
Device
E02.594.540

Sponsors

Centro Universitário UniFacid
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: subject between 18 and 60 years old; ability to understand and follow instructions in Portuguese; Glasgow Coma Scale of entry equal to or greater than 12; TBI time from 3 months.

Exclusion criteria

Exclusion criteria: subjects under 18 or over 60; limiting language and / or motor impairment; non-signature of the informed consent form, presence of important bone defects in the regions of the skull to be stimulated, presence of epilepsy after uncontrolled TBI.

Design outcomes

Primary

MeasureTime frame
Reduction in the level of anxiety measured through Beck Anxiety inventories.Each participant will have three assessments, one before treatment, one immediately after treatment and another three months after the end of the intervention.;Reduction in the level of depression measured through the Beck Depression inventories.Each participant will have three assessments, one before treatment, one immediately after treatment and another three months after the end of the intervention.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactLarisse de Carvalho

Centro Universitário UniFacid

larisse-ciriaco@hotmail.com+5586999301230

Outcome results

None listed

Source: REBEC (via WHO ICTRP)