NCT06612528

Brief Summary

Transcranial direct current stimulation (tDCS) can be used to temporarily and reversibly modulate brain functions and is an increasingly utilized tool to investigate the relationships between brain and behavior. This study aimed to identify the effects of tDCS on vocal quality, vocal range, neuromotor functioning of the larynx and self-reported vocal effort in vocally healthy singers. This is a triple-blinded, sham-controlled, randomized clinical trial. The participants were randomized to one of the three tDCS groups (primary motor cortex, cerebellum or sham). In each group a voice training was applied at the same tDCS time. The three groups are: (i) cerebellum; (ii) primary motor cortex (M1); (iii) sham. The tDCS parameters in the active groups are anodal - 2mA for 20 minutes, at the sham group the stimuli are finished 30 secondes before starting. Volunteers passed for 10 intervention days and they were evaluated for vocal performance before the sessions, in the day 5 of intervention, the last day of intervention (day 10) and 1 month later for follow up evaluation. Voice recordings was taken to assess the following vocal parameters: vocal range profile (VRP) at weak and strong intensities; vocal quality (jitter, shimmer, irregularity, glottal-to-noise excitation ratio, CPPS,HNR, and dysphonia acoustic index) at weak, habitual, and strong intensities; laryngeal diadochokinesis, and self-reported vocal effort using the adapted Borg CR10 scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 11, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

September 21, 2024

Last Update Submit

May 3, 2026

Conditions

Keywords

transcranial direct current stimulationtDCSFlexible tubevoicesingers

Outcome Measures

Primary Outcomes (1)

  • Vocal Range Profile

    Minimum fundamental frequency - f0; Maximum f0; Extension f0; Extension in Semitone; Minimum intensity; Maximum intensity and Area

    From enrollment to the end of evaluation at 6 weeks

Secondary Outcomes (1)

  • Vocal quality

    From enrollment to the end of evaluation at 6 weeks

Other Outcomes (2)

  • Larynx neuromuscular control and coordination

    From enrollment to the end of evaluation at 6 weeks

  • Self-reported vocal effort

    From enrollment to the end of evaluation at 6 weeks

Study Arms (3)

M1 and vocal exercise

EXPERIMENTAL

anodal tDCS over primary motor cortex associated with the vocal exercise using the flexible tube in water.

Device: tDCSDevice: Flexible tube in water

Cerebellum and vocal exercise

ACTIVE COMPARATOR

anodal tDCS over cerebellum associated with the vocal exercise using the flexible tube in water.

Device: tDCSDevice: Flexible tube in water

Sham and vocal exercise

PLACEBO COMPARATOR

tDCS sham associated with the vocal exercise using the flexible tube in water.

Device: tDCSDevice: Flexible tube in water

Interventions

tDCSDEVICE

The tDCS is a non-invasive brain stimulation technique. In this study, we used an intensity of 2mA for 20 minutes in two different areas. M1 group: the anode was over C5 (10-10 EEG system) and the cathode was placed over Fp2. For the Cerebellum group stimulation, the targeted anode area was 2 cm below the inion and the cathode over the deltoid muscle.

Also known as: transcranial direct current stimulation
Cerebellum and vocal exerciseM1 and vocal exerciseSham and vocal exercise

The exercise involved producing sustained /u/ vowels in ascending and descending scales, tailored to each participants vocal range. The flexible tube was 35 cm long, 1 cm in diameter, and 2 mm thick. One end of the tube was submerged 3 cm into a 500 ml bottle filled with water. Participants produced four sets of vocal exercises, each lasting 3 minutes, with 2-minute rests between sets, totaling 20 minutes of vocal therapy.

Also known as: Lax vox, Flexible tube
Cerebellum and vocal exerciseM1 and vocal exerciseSham and vocal exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Vocally healthy singers without formal singing education

You may not qualify if:

  • Smokers
  • Abnormalities in previous screening for voice symptoms
  • Exhibited signs and symptoms of laryngeal, pharyngeal, or respiratory diseases at the time of collection
  • Used neuroactive medications
  • Had metallic implants in the cervical region or above
  • Had any history of seizures or epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Interventions

Transcranial Direct Current StimulationHydrotherapy

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of three groups (M1, Cerebellum, or sham) using a computer-generated randomization list. All participants received 10 consecutive sessions of anodal tDCS combined with vocal exercises, except on weekends. Stimulation parameters and electrode placement varied by group: M1 - C5 (anode) and contralateral supraorbital (cathode); Cerebellum - cerebellar cortex (anode) and right deltoid (cathode); sham - identical electrode placement to the Cerebellum group, but with stimulation ceasing 30 seconds after onset. Vocal exercises consisted of four 3-minute bouts with a 2-minute rest between bouts. To maintain blinding, a towel was placed over the participants head during the procedure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 21, 2024

First Posted

September 25, 2024

Study Start

March 11, 2024

Primary Completion

October 10, 2025

Study Completion

December 20, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations