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Evaluation of the effectiveness of galvanic vestibular stimulation in the rehabilitation of Mielopatia associada ao HTLV-1

Electrophysiological Exams to Test Auditory Cognition and Postural Balance in HTLV-1 Associated Myelopathy (HAM)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9y34g7s
Enrollment
Unknown
Registered
2023-12-27
Start date
2020-07-30
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

HTLV I Associated Myelopathy

Interventions

This is an interventional study, characterized by Galvanic Vestibular Stimulation, as a new therapeutic strategy for balance rehabilitation. 150 individuals will be invited to participate in the resea
E05.723.402

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Fundação de Amparo à Pesquisa do Estado de Minas Gerais
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Control group: Composed of individuals with negative serology for HTLV-1 by the ELISA (Enzyme-linked-immunosorbent -assay) test; Group with HTLV-1 infection: Composed of former blood donors from Fundação Hemominas with seropositivity defined by the ELISA test and confirmed through WB (Western Blot) or molecular tests (Polymerase Chain Reaction - PCR); HAM group: individuals with sufficient clinical signs, according to the criteria proposed by the adapted WHO (GRASSI et al, 2011; CASTRO-COSTA, 2006), classified according to the adapted Expanded Functional Disability Scale (EDSS) and OSAME presenting classification from two on both scales.

Exclusion criteria

Exclusion criteria: Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), positive Venereal Disease Research Laboratory (VDRL) test; History of stroke and epilepsy ; Inability to remain in the examination position; Recurrent episodes of vertigo or history of previously diagnosed peripheral vestibulopathy; Patients with a pacemaker or any device that may undergo changes resulting from the use of EVG; Cognitive changes justified by some other pathology associated with Parkinson's disease; Individuals who are alienated and unable to answer for their own actions.

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in postural balance, verified through the Berg Balance Scale evaluation method, based on the observation of an increase in the score, in which results above or equal to 45 are satisfactory after intervention; Using the Time up and go test method, we will observe a decrease in the post-intervention score, in which values below 10 or between 10 and 19 are acceptable parameters as they configure values for independent individuals with a good balance; It is expected to verify, using the computerized posturography method, an increase in the stability limit comparing pre and post intervention values and an increase in the values of visual, somatosensory, vestibular and general balance indexes reaching values above 90%, compatible with values of reference of elderly individuals without the pathology. ;It is expected to find an improvement in voluntary attention, verified through the method of comparing the results of the P300 exam, based on the observation of a decrease in latency and an increase in wave amplitude of at least 30 ms and 5 µV, respectively, pre and post -intervention.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactLudimila Labanca

Universidade Federal de Minas Gerais

ludlabanca@gmail.com55 31 34093417

Outcome results

None listed

Source: REBEC (via WHO ICTRP)