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Effect of an intervention with Electrical Stimulation of the brain through the skull bones associated with Motor Exercises on motor symptoms in people with Parkinson's disease

Effect of an intervention with Electrical Stimulation on the brain through the skull bones combined with exercises on locomotion and balance in individuals with Parkinson's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6zvxsdb
Enrollment
Unknown
Registered
2024-10-21
Start date
2025-02-01
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

Postural Balance

Interventions

This is a two-arm, triple-blind, sham-controlled randomized controlled clinical study. Thirty-four individuals with Parkinson's disease (PD) will be randomly distributed (by a blinded assessor) into t
G11.427.410.698.277
E02.331.750

Sponsors

Faculdade de Ciências e Tecnologia - Universidade Estadual Paulista
Lead Sponsor
Faculdade de Ciências e Tecnologia - Universidade Estadual Paulista
Collaborator

Eligibility

Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals with Parkinson's Disease; of both sexes; they must have the disease diagnosed by doctors following the criteria determined by the London Brain Bank; age equal to or greater than 50 years; and present independent locomotion (without assistance from people or use of auxiliary devices)

Exclusion criteria

Exclusion criteria: Staging greater than 3 on the Hoehn & Yahr scale; orthopedic and vision problems that make it impossible to comply with the experimental protocol; presence of another neurological disease, in addition to Parkinson's Disease (PD); indicative of cognitive decline (score less than 24 on the Mini Mental State Examination - MMSE); individuals at risk of receiving Transcranial Direct Current Stimulation - tDCS (e.g., neural implants, individuals with deep brain stimulation implants, pacemaker, history of seizures and epilepsy); have uncontrolled diseases (e.g. high blood pressure and diabetes); experience intense pain or discomfort that makes it impossible and difficult to perform motor exercises; and not understanding the motor exercises proposed in the intervention

Design outcomes

Primary

MeasureTime frame
It is expected that multiple sessions of tDCS combined with motor exercises will improve gait control by decreasing the stride length variability.;It is expected that multiple sessions of tDCS combined with motor exercises improve postural control observed by the reduction in the root mean square (RMS) of body sway in the anteroposterior direction;It is expected that multiple sessions of tDCS combined with motor exercises will improve functional mobility observed by decreasing the time to complete the Timed Up and Go test (TUG);It is expected that multiple sessions of tDCS combined with motor exercises will improve balance as observed by the increase in the MiniBEST-Test score.

Secondary

MeasureTime frame
It is expected that multiple sessions of tDCS combined with motor exercises improve gait control observed by modulation in the spatio-temporal gait variables (gait speed, stride length and duration, cadence, swing time and time in double support and variability the length of the stride).;It is expected that multiple sessions of tDCS combined with motor exercises will improve postural control observed by the decrease in RMS in the medio-lateral direction, in the speed of body sway in the anteroposterior and medio-lateral directions, in the area and in the range of body sway;It is expected that multiple sessions of tDCS combined with motor exercises will increase the activity of the prefrontal and primary motor cortices during walking and balance control.

Countries

Brazil

Contacts

Public ContactVictor Beretta

Universidade Estadual Paulista (UNESP), Faculdade de Ciências e Tecnologia (FCT)

victor.beretta@unesp.br+55(18)32295715

Outcome results

None listed

Source: REBEC (via WHO ICTRP)