Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Not Applicable

Terminated

• Conditions: Ankle Sprains; Musculoskeletal Injury
• Interventions: Other: Transcranial Direct Current Stimulation; Other: Sham Transcranial Direct Current Stimulation; Other: Physical Therapy

• Registration Number: NCT04902274
• Lead Sponsor: Keller Army Community Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-19
• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-17
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation plus Physical Therapy	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.
Transcranial Direct Current Stimulation plus Physical Therapy	Transcranial Direct Current Stimulation	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.
Sham Transcranial Direct Current Stimulation plus Physical Therapy	Sham Transcranial Direct Current Stimulation	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.
Sham Transcranial Direct Current Stimulation plus Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
Composite Pain Rating	Change from Baseline to 8-weeks	Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Keller Army Community Hospital - Arvin Physical Therapy; 🇺🇸 West Point, New York, United States