Modulating Cortical Excitability to Improve Functional Movements in Individuals With Patellofemoral Pain

NCT06565520 | Recruiting FDA Device

• 1 other identifier: UNLV-2022-69
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study sought to investigate whether modulation of cortical excitability of the gluteal musculature, via tDCS paired with exercise, will reduce the amount the knee caves in during functional tasks in individuals with PFP. The objective is the explore if having tDCS target the area of the brain controlling hip muscles, when paired with exercise, will be more effective in reducing the amount the knee caves in for individuals with PFP versus those who receive exercise alone as their treatment. The aim is to contribute our findings to the growing knowledge in this area in order to help establish the possibility, and feasibility, of its use in clinical settings to strengthen traditional treatments for this patient population.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (4)

• trunk lean angle

  Baseline and Immediately after intervention

• knee frontal plane projection angle

  Baseline and Immediately after intervention

• hip frontal plane projection angle

  Baseline and Immediately after intervention

• dynamic valgus index

  Baseline and Immediately after intervention

Study Arms (2)

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

Device: transcranial direct current stimulator

Sham

SHAM COMPARATOR

Device: transcranial direct current stimulator

Interventions

transcranial direct current stimulator DEVICE

The total amount of participation time per qualified subject will be approximately 150 minutes over two sessions. The participant screening session will take approximately 30 minutes, which is an appropriate amount of time to complete all screening tasks. The tDCS and sham sessions will take approximately a total of 120 minutes over two sessions. The first session will include a screening (30 minutes) to ensure they qualify for the study, followed by a treatment session (60 minutes): including non-invasive brain stimulation combined with hip strengthening exercises and functional movement testing at UNLV Maryland Campus. Subjects will return for a second treatment session (60 minutes) 2 weeks after the first.

Sham; Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

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

You may qualify if:

• are between 18 and 45 years old
• have had patellofemoral pain (PFP; kneecap pain) on one side for at least 3 months, and 3) the knee does cave in when performing functional movements.

You may not qualify if:

• do not have pain coming from the kneecap during screening;
• have a history of knee injury or surgery,
• have a history of seizures and/or taking anti-seizure medication,
• have an implanted device that interacts with electric current,
• have a history of balance disorder,
• currently are pregnant or think they may be pregnant.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Kai Yu Ho, PhD

  UNLV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Yu Ho, PhD

CONTACT

7028952629; kaiyu.ho@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 22, 2024
• Study Start: April 24, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)