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Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Primary Purpose

Ankle Sprains, Musculoskeletal Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Physical Therapy
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Keller Army Community Hospital - Arvin Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation plus Physical Therapy

Sham Transcranial Direct Current Stimulation plus Physical Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Composite Pain Rating
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Composite Pain Rating
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2021
Last Updated
April 21, 2022
Sponsor
Keller Army Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04902274
Brief Title
Effectiveness of Transcranial Direct Current Stimulation (tDCS).
Official Title
Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Musculoskeletal Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Fellowship Graduation December 2021
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keller Army Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Musculoskeletal Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation plus Physical Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Sham Transcranial Direct Current Stimulation plus Physical Therapy
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite Pain Rating
Description
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Time Frame
Change from Baseline to 4-weeks
Title
Composite Pain Rating
Description
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Time Frame
Change from Baseline to 8-weeks
Secondary Outcome Measure Information:
Title
Self-Reported Function
Description
Patient report of function assessed by Single Assessment Numeric Evaluation
Time Frame
Change from Baseline to 4-weeks
Title
Self-Reported Function
Description
Patient report of function assessed by Single Assessment Numeric Evaluation
Time Frame
Change from Baseline to 8-weeks
Title
Muscle Strength
Description
Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry
Time Frame
Change from Baseline to 4-weeks
Title
Muscle Strength
Description
Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry
Time Frame
Change from Baseline to 8-weeks
Title
Proprioception
Description
Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest
Time Frame
Change from Baseline to 4-weeks
Title
Proprioception
Description
Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest
Time Frame
Change from Baseline to 8-weeks
Title
Dynamic balance
Description
Dynamic balance assessed by the Y-balance Test
Time Frame
Change from Baseline to 4-weeks
Title
Dynamic balance
Description
Dynamic balance assessed by the Y-balance Test
Time Frame
Change from Baseline to 8-weeks
Title
Muscle Power
Description
Single leg hop test for distance
Time Frame
Change from Baseline to 4-weeks
Title
Muscle Power
Description
Single leg hop test for distance
Time Frame
Change from Baseline to 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Keller Army Community Hospital - Arvin Physical Therapy
City
West Point
State/Province
New York
ZIP/Postal Code
10966
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Transcranial Direct Current Stimulation (tDCS).

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