Balance Training With tDCS for CAI

NCT04390048 | Completed Results FDA Device

• 1 other identifier: 20200090
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Injuries and Disorders

Keywords

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Self-reported Functional Scores

  Baseline

• Self-reported Functional Scores

  4 weeks

• Spinal Reflex Excitability

  Baseline

• Spinal Reflex Excitability

  4 weeks

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

  Baseline

Study Arms (2)

Anodal tDCS and Balance Training (BT) Group

EXPERIMENTAL

Participants will undergo 4 weeks of BT under anodal tDCS treatment.

Device: Anodal tDCS

Sham tDCS and BT Group

SHAM COMPARATOR

Participants will undergo 4 weeks of BT under sham tDCS.

Device: Sham tDCS

Interventions

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.

Anodal tDCS and Balance Training (BT) Group

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.

Sham tDCS and BT Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Brian Arwari
• Organization: University of Miami

[email protected]

305-284-5418

Study Officials

• Brian Arwari

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: September 20, 2021
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: March 6, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)