NCT06109727

Brief Summary

The aim of this study is to investigate the effect of transcranial electrical stimulation (tDCS) on motor performance, autonomic control and attentional and executive functions in young individuals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 16, 2023

Last Update Submit

October 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of tDCS on motor performance

    * Bilateral coordination of different walking conditions will be assessed by percentage (%) * The static equilibrium will be evaluated by the average amplitude of displacement of the center of pressure in mean lateral and anteroposterior directions (cm)

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Effect of tDCS on functional mobility and dynamic balance

    Through study completion, an average of 1 year

  • Effect of variability of the heart rate

    Through study completion, an average of 1 year

  • Efect of tDCS on attentional and executive functions

    Through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

In the intervention group, the anodic stimulations will start after a ramp period of 30 s, followed by 20 min at 2 mili ampere and will end with a ramp of 30 s.

Device: cerebellar transcranial electrical stimulation

Placebo

PLACEBO COMPARATOR

In the simulated configuration, the ramp of 30 s will be immediately followed by the ramp of 30 s and without any current (Sham Group)

Device: cerebellar transcranial electrical stimulation

Interventions

Cerebellar transcranial electrical stimulation - 20 mA - 20 min

InterventionPlacebo

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • participant of both sex

You may not qualify if:

  • history of neurological or psychological diseases;
  • use of any medications that may affect balance control, such as sedative drugs;
  • presence of skeletal muscle injuries such as fracture, ligament injury, muscle tension or low back pain that restricts movement;
  • presence of any sign of involvement of the spinal cord;
  • visual or hearing impairment;
  • musculoskeletal deformities in the lower or upper extremities that may affect the participant's standing posture;
  • skin conditions (e.g., eczema and injuries) on the scalp
  • presence of metal inside the head (outside the mouth) such as splinters, surgical clips or fragments of solder or metal work;
  • implanted devices such as cardiac pacemaker, cochlear implant;
  • score less than 24 points in the Mini Mental State Examination (MMSE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tais Malysz

Porto Alegre, Rio Grande do Sul, 90630150, Brazil

Location

Study Officials

  • Taís Malysz

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professora

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 31, 2023

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations