Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Keller Army Community Hospital

Status: Terminated

Conditions: Musculoskeletal Injury; Ankle Sprains

Treatments: Other: Physical Therapy; Other: Transcranial Direct Current Stimulation; Other: Sham Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04902274

19KACH005

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups

Transcranial Direct Current Stimulation plus Physical Therapy

Experimental group

Description:

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.

Treatment:

Other: Physical Therapy

Other: Transcranial Direct Current Stimulation

Sham Transcranial Direct Current Stimulation plus Physical Therapy

Sham Comparator group

Description:

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.

Treatment:

Other: Physical Therapy

Other: Sham Transcranial Direct Current Stimulation