Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Musculoskeletal Rehabilitation.

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.

Study Overview

• Status: Terminated
• Conditions: Ankle Sprains; Musculoskeletal Injury
• Intervention / Treatment: Other: Transcranial Direct Current Stimulation; Other: Physical Therapy; Other: Sham Transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • West Point, New York, United States, 10966
      • Keller Army Community Hospital - Arvin Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-40
2. Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain

Exclusion Criteria:

1. Self-Reported Pregnancy
2. Being treated for and on medication for a mental health diagnosis
3. Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
4. Open wound or dermatologic lesion on the head or region of application
5. Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
6. Epilepsy or history of seizures
7. Participants who are not fluent in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Direct Current Stimulation plus Physical Therapy; Participants in the experimental group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute application of tDCS during each treatment session via the Halo Sport (Halo Neuroscience, San Francisco, CA) headset. 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.	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: 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.
Sham Comparator: Sham Transcranial Direct Current Stimulation plus Physical Therapy; Participants in the sham control group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute sham tDCS treatment, where the patient is wearing the tDCS headset, but stimulation is only applied for 30 seconds of the 20-minute period. 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Pain Rating	Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain	Change from Baseline to 4-weeks
Composite Pain Rating	Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain	Change from Baseline to 8-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Function	Patient report of function assessed by Single Assessment Numeric Evaluation	Change from Baseline to 4-weeks
Self-Reported Function	Patient report of function assessed by Single Assessment Numeric Evaluation	Change from Baseline to 8-weeks
Muscle Strength	Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry	Change from Baseline to 4-weeks
Muscle Strength	Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry	Change from Baseline to 8-weeks
Proprioception	Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest	Change from Baseline to 4-weeks
Proprioception	Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest	Change from Baseline to 8-weeks
Dynamic balance	Dynamic balance assessed by the Y-balance Test	Change from Baseline to 4-weeks
Dynamic balance	Dynamic balance assessed by the Y-balance Test	Change from Baseline to 8-weeks
Muscle Power	Single leg hop test for distance	Change from Baseline to 4-weeks
Muscle Power	Single leg hop test for distance	Change from Baseline to 8-weeks

Collaborators and Investigators

• Sponsor: Keller Army Community Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 19KACH005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No