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Neuromodulation associated with virtual reality for the treatment of migraine.

Transcranial Electrostimulation by Current Continuous associated with Virtual Reality in the Treatment of Migraine - Randomized Clincal Trial Explanatory

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7sxfdpt
Enrollment
Unknown
Registered
2022-01-31
Start date
2020-10-01
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

Migranea without Aura

Interventions

The randomization list for the 116 participants will be generated using the Randon Allocation software, where four groups will be created: Control (n=29), ETCC (submitted to transcranial direct curren
n=29) and ETCC+RV (submitted to electrical stimulation transcranial transmission by direct current associated with virtual reality, performed in a concomitantly
n=29). The numbers generated will be contained in 116 envelopes opaque sealed, numbers will be randomly sorted into "Control", "ETCC", "RV" and "ETCC+RV", in order to maintain the confidentiality of t
E02 VS3.003.001.006

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: female individuals, aged between 18 and 50 years with migraine without aura, who have at least 15 days of pain from headache per month, of which at least 08 migraine attacks as per International Headache Society criteria - ICHD-3 (IHS, 2013).

Exclusion criteria

Exclusion criteria: history of neurological, psychiatric, or medical illness acute; family history of epilepsy; pregnancy or lactation; cardiac pacemaker; bad cranial formation; previous surgery involving head implants; presence of vestibulopathies (labyrinthitis, dizziness, vertigo); any system treatment central nervous system by peripheral neurostimulation prior to research.

Design outcomes

Primary

MeasureTime frame
Dor, avaliada através do uso de uma escala analógica visual de percepção de dor (VAS), pela percepção do tipo de dor utilizando o Questionário de dor McGill, relatos do paciente quando à duração dos ataques (média mensal), número de dias mensais com dor de cabeça e número de analgésicos utilizados (média mensal) através do Diário de Episódios de Dor de Cabeça e Enxaqueca, a partir da constatação de uma variação de pelo menos 5% nas medições pré e pós-intervenção.—

Secondary

MeasureTime frame
Thermal pattern radiated by the skin of the frontal region and functionality, which for this study will be understood by postural stability, motion sickness, panic and agoraphobia; and quality of life, measured through infrared thermography, Clinical Test of Sensory Integration and Balance modified (mCTSIB) and Clinical Test of Sensory Integration and Balance (DGI), Dizziness Handicap Inventory (DHI), Panic and Agoraphobia Scale – PAS and WHOQOL -BREF, respectively, based on the finding of a variation of at least 5% in pre- and post-immediate intervention and 30-day post-intervention measurements.—

Countries

Brazil

Contacts

Public ContactBruno Fracasso
brunofracasso@hotmail.com+55(51)95690166

Outcome results

None listed

Source: REBEC (via WHO ICTRP)