Balance Training With tDCS for CAI

Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)

The purpose of this research study is to examine the efficacy of non-invasive brain stimulation in addition to balance exercise for chronic ankle instability (CAI), a condition that develops following an initial ankle sprain, usually because of loose or unstable ankle joints.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries and Disorders
• Intervention / Treatment: Device: Anodal tDCS; Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects should be neurologically sound
• Subjects should have abilities to maintain a single-leg stance at least for 10 seconds.
• A history of ankle sprain
• A history of ankle joint giving ways
• Current feelings of ankle joint instability

Exclusion Criteria:

• Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with Transcranial Magnetic Stimulation (TMS), deep brain stimulation for any disorder will be excluded.
• Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
• A history of balance or vestibular disorder
• A history of previous surgeries to the musculoskeletal structures in either limb of the lower extremity
• A history of a fracture in either limb of the lower extremity requiring realignment
• A history of acute injuries to the lower extremity joints in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
• A history of herniated disc
• Poorly controlled headache
• Hypersensitivity to electrical or magnetic stimulation
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodal tDCS and Balance Training (BT) Group; Participants will undergo 4 weeks of BT under anodal tDCS treatment.	Device: Anodal tDCS; An anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Anodal tDCS will deliver a low electrical current stimulation at 2 milliamps (mA). Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes.
Sham Comparator: Sham tDCS and BT Group; Participants will undergo 4 weeks of BT under sham tDCS.	Device: Sham tDCS; An anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Sham tDCS will deliver a low electrical current stimulation at 2 mA and will be turned off 30 seconds following the application. Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Postural Balance	Center of Pressure (COP) velocity (cm/s)	Baseline
Static Postural Balance	Center of Pressure (COP) velocity (cm/s)	Week 4
Active Motor Threshold (AMT)	The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)	Baseline
Active Motor Threshold (AMT)	The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Functional Scores	The percentage score of the Foot and Ankle Ability Measure (FAAM). The total percentage score ranges from 0-100. The higher score indicates a better ankle function.	Baseline
Self-reported Functional Scores	The percentage score of the Foot and Ankle Ability Measure (FAAM). The total percentage score ranges from 0-100. The higher score indicates a better ankle function.	4 weeks
Spinal Reflex Excitability	The maximal peak-to-peak amplitude ratios of the Hoffman reflex (H-reflex) and the motor response (M-wave) of the soleus muscle were calculated by normalizing the maximal H-reflex amplitude to the maximal M-wave amplitude (Hmax/Mmax ratio). A higher Hmax/Mmax indicates a greater spinal reflex excitability.	Baseline
Spinal Reflex Excitability	The maximal peak-to-peak amplitude ratios of the Hoffman reflex (H-reflex) and the motor response (M-wave) of the soleus muscle were calculated by normalizing the maximal H-reflex amplitude to the maximal M-wave amplitude (Hmax/Mmax ratio). A higher Hmax/Mmax indicates a greater spinal reflex excitability.	4 weeks
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)	The soleus active muscle response, due to transcranial magnetic stimulation (TMS) pulses over the motor cortex, will be used for quantifying the motor evoked potential.	Baseline
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)	The soleus active muscle response, due to transcranial magnetic stimulation (TMS) pulses over the motor cortex, will be used for quantifying the motor evoked potential.	4 weeks
Dynamic Postural Control as Measured by the Reach Distance	The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).	Baseline
Dynamic Postural Control as Measured by the Reach Distance	The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).	4 weeks
Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop	The completion time (seconds) for the lateral hop will be measured. Each trial consists of 10 lateral hops. The average completion time of 3 trials will be reported. The completion time will be recorded using a stopwatch in seconds.	Baseline
Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop	The completion time (seconds) for the lateral hop will be measured. Each trial consists of 10 lateral hops. The average completion time of 3 trials will be reported. The completion time will be recorded using a stopwatch in seconds.	4 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Brian Arwari, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Ankle Instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 20200090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No