Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue.

NCT ID: NCT05210231

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2023-05-05

Brief Summary

The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be recruited via social networks, WhatsApp and emails and must be currently engaged in moderate physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of assessment. In addition, participants will be asked not to perform any type of strenuous exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. The study will consist of three sessions, with an interval of 72 hours between them.

Conditions

Asymptomatic Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Active anodal tDCS

The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: OTHER

The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.

Sham anodal tDCS

The direct electric current will apply through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For the sham condition, the electrodes will be placed at the same positions as for the anodal tDCS. However, the stimulator will turn off after 30 s of stimulation. As a result, subjects will report the same sensory feelings from the beginning of the real tDCS conditions, specifically itching and tingling feelings on the scalp for the first few seconds of tDCS, but not thereafter, whether or not the stimulation will continue or stop.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: OTHER

The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.

Interventions

Transcranial Direct Current Stimulation

The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ranging between 18 to 35 years, all genders.
• Healthy subjects
• Moderate physical activity (evaluated by IPAQ questionnaire)
• Do not perform any exhausting exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed.

Exclusion Criteria

• Subjects with trauma in the last three weeks or previous surgeries on the upper extremity, patients with pre-existing neurological or rheumatic conditions, pregnancy, medical history of epilepsy the convulsive event, subjects under analgesic drug treatment or have ingested drugs with central action in the last 72 hours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Mauro Barone

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristian Mendoza, MsC

Role: PRINCIPAL_INVESTIGATOR

University of Gran Rosario

Locations

University of Gran Rosario

Rosario, Santa Fe Province, Argentina

Countries

Argentina

Other Identifiers

tDCS and Rotator Cuff

Identifier Type: -

Identifier Source: org_study_id