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Completed

NCT Number: NCT04390048

Balance Training With tDCS for 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.

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Key information

Conditions

Ankle Injuries and Disorders Ankle Injuries Disease Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal tDCS

Device

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 tDCS

Device

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.

Primary outcomes

  1. Static Postural Balance

    Time frame: Baseline

    Center of Pressure (COP) velocity (cm/s)

  2. Static Postural Balance

    Time frame: Week 4

    Center of Pressure (COP) velocity (cm/s)

  3. Active Motor Threshold (AMT)

    Time frame: Baseline

    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. Active Motor Threshold (AMT)

    Time frame: 4 weeks

    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)

Secondary outcomes

  1. Self-reported Functional Scores

    Time frame: Baseline

    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.

  2. Self-reported Functional Scores

    Time frame: 4 weeks

    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.

  3. Spinal Reflex Excitability

    Time frame: Baseline

    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. Spinal Reflex Excitability

    Time frame: 4 weeks

    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.

  5. Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)

    Time frame: Baseline

    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.

  6. Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)

    Time frame: 4 weeks

    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.

  7. Dynamic Postural Control as Measured by the Reach Distance

    Time frame: Baseline

    The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).

  8. Dynamic Postural Control as Measured by the Reach Distance

    Time frame: 4 weeks

    The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).

  9. Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop

    Time frame: Baseline

    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.

  10. Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 15, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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