NCT03870139

Brief Summary

Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on quadriceps function are lacking. This study aims to investigate the effects of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) on quadriceps strength 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-volunteers

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2 healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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
19 days until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

March 8, 2019

Last Update Submit

May 7, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Isometric quadriceps strength

    Maximal isometric voluntary contraction (Kgf)

    Pre and Post-test (immediately after tDCS)

Secondary Outcomes (2)

  • Isometric quadriceps strength

    During stimulation

  • Isometric quadriceps strength

    10 minutes post-stimulation

Study Arms (4)

Cerebral stimulation

ACTIVE COMPARATOR

Active transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the dominant lower limb) and supraorbital cathode (ipsilateral to the dominant lower limb).

Device: Cerebral stimulation

Combined stimulation 1

EXPERIMENTAL

Active peripheral electrical stimulation (PES\_sensorial) combined with active transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). PES\_sensorial: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.

Device: Cerebral stimulationDevice: Peripheral stimulation

Peripheral stimulation

ACTIVE COMPARATOR

Active peripheral electrical stimulation (PES\_motor). PES: 15 minutes, 30Hz (frequency), 100µs (pulse duration), intensity at motor level.

Device: Peripheral stimulation

Combined stimulation 2

EXPERIMENTAL

Active sensorial peripheral electrical stimulation (PES\_sensorial) combined with active motor peripheral electrical stimulation (PES\_motor) PES\_sensorial: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level PES\_motor: 15 minutes, 30Hz (frequency), 100µs (pulse duration), intensity at motor level.

Device: Cerebral stimulationDevice: Peripheral stimulation

Interventions

Cerebral stimulationDEVICE

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.

Also known as: Transcranial direct current stimulation
Cerebral stimulationCombined stimulation 1Combined stimulation 2
Peripheral stimulationDEVICE

Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia. Moreover, recent evidence has shown that PES can activate brain motor areas such as primary motor cortex.

Combined stimulation 1Combined stimulation 2Peripheral stimulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
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 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
Assistant Professor - Physical Therapy Department

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 11, 2019

Study Start

March 30, 2019

Primary Completion

April 30, 2019

Study Completion

May 7, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)