Effects of tDCS on Motor Cortex During ACL Recovery

NCT06818201 | Recruiting DMC

• 1 other identifier: UCV/2023-2024/053
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Anterior Cruciate Ligament (ACL) is a prevalent injury, particularly among young and physically active individuals. The efficacy of transcranial direct current stimulation (tDCS) and exercise-based rehabilitation on neuromuscular control in post-ACL reconstruction patients is evaluated, and these techniques are combined.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

motor control; Anterior Cruciate Ligament; exercise; tDCS

Outcome Measures

Primary Outcomes (1)

• Electromyography (EMGs)

  The The Surface EMG amplitudes of the quadriceps and hamstring muscles. The main device, Musclelab, is equipped with a Musclelab force sensor and wireless surface elec-tromyography (EMGs). Electrode placement will follow the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscle (SENIAM) protocol from the European Concerted Action in the Biomedical Health and Research Program (BIOMED II). The instructions provided to the patients will be to perform the movement with the max-imum possible contraction, and as rapidly as possible, to achieve the highest peak of force. The patient will carry out 3 familiarization repetitions at a submaximal inten-sity at the beginning of each repetition, and it will begin with the non-surgical ex-tremity, followed by the tests on the surgical extremity. Three effective MVIC attempts will be conducted, each lasting 5 seconds, with a 30-second rest interval between each repetition .

  At baseline, 90days post-surgery, 180days post-surgery

Secondary Outcomes (6)

• Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL)

  At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery

• Lysholm Scale

  At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery

• Functional Jump Test

  60days post-surgery, 90days post-surgery and 180days post-surgery

• Tampa Scale of Kinesiophobia

  At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery

• Pain Catastrophizing Scale

  At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery

Study Arms (2)

NIBS + rehabilitation

EXPERIMENTAL

The intervention using tDCS will be performed through the Home tDCS device (Ionclinics®). It will be introduced in the first part of the rehabilitation, during activation, because the required exercises will be of lower intensity, complexity, and more compatible with this intervention.

Device: NIBS; Procedure: Rehabilitation

ShamNIBS + RHB

SHAM COMPARATOR

The device will be configured to produce an ascending ramp lasting 30 seconds, identical to the one used in the experimental group, followed by a descending ramp of another 30 seconds. Thus, the control group will experience a sensation of tingling on the scalp, similar to that felt by the experimental group. This stimulation will have a total duration of 1 minute, which will not be sufficient to induce changes in cortical excitability

Procedure: Rehabilitation; Behavioral: Sham Comparator

Interventions

NIBS DEVICE

A total of 16 sessions will be scheduled, distributed over 8 weeks (2 sessions/week). The continuous current intensity will be set at 2 mA, for 20 minutes. Two electrodes, anode (red) and cathode (black), will be used along with two sponge pads with conductive gel, all combined into a helmet for each patient. The electrodes will be placed according to the international 10-20 system in tDCS. The stimulated area will be the primary motor cortex (M1), so the anode will be placed at the C3 or C4 points and the cathode will be placed at the contralateral supraorbital area Fp1 or Fp2.

NIBS + rehabilitation

Rehabilitation PROCEDURE

This protocol will consist of 72 sessions, distributed as 3 sessions per week over a period of 24 weeks. Strength will be the prioritized method of work and will be present in all phases. Additionally, periodic measurements will be included to ensure that the patient is making adequate progress and meets the necessary progression criteria to advance to the next phase

NIBS + rehabilitation; ShamNIBS + RHB

Sham Comparator BEHAVIORAL

The device will be configured to produce an ascending ramp lasting 30 seconds, identical to the one used in the experimental group, followed by a descending ramp of another 30 seconds. Thus, the control group will experience a sensation of tingling on the scalp, similar to that felt by the experimental group. This stimulation will have a total duration of 1 minute, which will not be sufficient to induce changes in cortical excitability

ShamNIBS + RHB

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis complete ACL tear through clinical evaluation and MRI imaging.
• Patients who have received surgical intervention.
• Aged between 16 and 40 years.
• Tegner activity level of 4 or higher.

You may not qualify if:

• Rupture, such as tendons, cartilage, bones, or ligaments.
• Absence of any pre-existing or current lower limb pathologies, such as open surgeries, knee arthroscopies, or femur/tibia fractures.
• Neuromuscular or metabolic diseases.
• Concussion within the past six months are not eligible.
• Cranial surgery or have intracranial metal clips are ineligible.
• Taking medications that affect neuronal activity.
• Neurological diseases or disorders are not eligible for participation.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Catholic Univerity of Valencia

Valencia, Valencia, 46001, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Juan Vicente Mampel, PhD

CONTACT

+34963637412; juan.vicente@ucv.es

OTRI OTRI

CONTACT

otri@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The groups will be randomly assigned, and a double-blind procedure will be employed as the masking technique. Subject selection will be conducted randomly using the EPIDAT 3.1 program. Both the participants and the researcher responsible for data collection will remain unaware of the assigned intervention and the results obtained, respectively, until the study's conclusion. An independent researcher will generate a table of random numbers using an Excel formula to blind data collectors and outcome adjudicators, thereby ensuring unbiased outcome ascertainment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To evaluate the effects of combined tDCS and exercise-based rehabilitation targeting neuromuscular control, comparing it to sham tDCS treatment.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 10, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): December 27, 2027
• Study Completion (Estimated): December 27, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-01

Locations

ES (1)