Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Ankle Sprains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04902274
• Other study ID #: 19KACH005
• Status: Terminated
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 17, 2021

Study information

• Verified date: May 2021
• Source: Keller Army Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Musculoskeletal Injury

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Keller Army Community Hospital - Arvin Physical Therapy	West Point	New York

Sponsors (1)

Lead Sponsor	Collaborator
Keller Army Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Pain Rating	Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain	Change from Baseline to 4-weeks
Primary	Composite Pain Rating	Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain	Change from Baseline to 8-weeks
Secondary	Self-Reported Function	Patient report of function assessed by Single Assessment Numeric Evaluation	Change from Baseline to 4-weeks
Secondary	Self-Reported Function	Patient report of function assessed by Single Assessment Numeric Evaluation	Change from Baseline to 8-weeks
Secondary	Muscle Strength	Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry	Change from Baseline to 4-weeks
Secondary	Muscle Strength	Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry	Change from Baseline to 8-weeks
Secondary	Proprioception	Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest	Change from Baseline to 4-weeks
Secondary	Proprioception	Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest	Change from Baseline to 8-weeks
Secondary	Dynamic balance	Dynamic balance assessed by the Y-balance Test	Change from Baseline to 4-weeks
Secondary	Dynamic balance	Dynamic balance assessed by the Y-balance Test	Change from Baseline to 8-weeks
Secondary	Muscle Power	Single leg hop test for distance	Change from Baseline to 4-weeks
Secondary	Muscle Power	Single leg hop test for distance	Change from Baseline to 8-weeks