Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Summary

Reducing pain and recovery of strength and function are major challenges in physical therapy. Transcranial direct current stimulation (tDCS) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. Acute application of tDCS has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tDCS has also been shown to reduce pain in patients with chronic pain conditions. Using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tDCS plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. We hypothesize that the group using tDCS will demonstrate superior outcomes in all variables of interest.

Conditions

• Ankle Sprains
• Musculoskeletal Injury

Interventions

OTHER

Transcranial Direct Current Stimulation

The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the tDCS group will complete a 20-minute tDCS session while performing the warm-up.

OTHER

Sham Transcranial Direct Current Stimulation

The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the sham tDCS group will complete a 20-minute sham-tDCS session while performing the warm-up, but the app will discontinue the treatment after 30 seconds.

OTHER

Physical Therapy

After the tDCS session is complete, the patient will complete treatment consistent with the standard of care for rehabilitation of acute ankle inversion sprain. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes. Patients will also perform a standardized home exercise program that reinforces the in-clinic treatment.

Sponsors & Collaborators

• Keller Army Community Hospital

  lead FED

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-19

Primary Completion

2021-12-17

Completion

2021-12-17

Countries

• United States

Study Locations