Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Study Overview
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Brief Summary
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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.

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

Conditions
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Ankle Sprains, Musculoskeletal Injury

Intervention / Treatment
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* Other: Transcranial Direct Current Stimulation
* Other: Sham Transcranial Direct Current Stimulation
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-40 Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain Exclusion Criteria: Self-Reported Pregnancy Being treated for and on medication for a mental health diagnosis Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months Open wound or dermatologic lesion on the head or region of application Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.). Epilepsy or history of seizures Participants who are not fluent in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Direct Current Stimulation plus Physical Therapy<br>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<br>* 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.<br>Other: Physical Therapy<br>* 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.<br>|
| Sham Comparator: Sham Transcranial Direct Current Stimulation plus Physical Therapy<br>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: Sham Transcranial Direct Current Stimulation<br>* 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.<br>Other: Physical Therapy<br>* 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.<br>|

What is the study measuring?
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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 |