NCT03870178

Brief Summary

Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking. This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Jan 2019

Typical duration for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

March 8, 2019

Last Update Submit

April 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Isometric trunk extension

    Maximal isometric voluntary contraction (Kgf)

    Pre and Post-test (immediately after tDCS)

  • Trunk muscle endurance

    Time to task failure (TTF) on the Sorensen test

    Pre and Post-test (immediately after tDCS)

Secondary Outcomes (4)

  • Isometric trunk extension

    15 minutes post-stimulation

  • Isometric trunk extension

    30 minutes post-stimulation

  • Trunk muscle endurance

    15 minutes post-stimulation

  • Trunk muscle endurance

    30 minutes post-stimulation

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Anodal tDCS over trunk motor cortex representation. Intensity: 2mA Time: 20 minutes

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Anodal tDCS over trunk motor cortex representation. Itensity: 2mA Time: 20 minutes (30s ON)

Device: Transcranial direct current stimulation (tDCS)

Interventions

The noninvasive and nonpharmacological weak electrical current applied to the scalp to modulate cortical excitability.

Active tDCSSham tDCS

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.

You may not qualify if:

  • Musculoskeletal or neurological disorder
  • Under medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202020, Brazil

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Fuad Hazime, PhD

    Department of Physical Therapy. Federal University of Piaui

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor - Physical Therapy Department

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 11, 2019

Study Start

January 2, 2019

Primary Completion

November 30, 2019

Study Completion

April 30, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations