Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease

NCT04783493 | Unknown DMC

• 1 other identifier: USaoPaulo
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Dopaminergic drugs partially alleviate gait problems in Parkinson's disease, but the effects are not sustained in the long-term. Particularly, the freezing of gait, balance problems and other gait issues directly impacts patients' quality of life. Experimental epidural spinal cord stimulation studies have suggested positive effects on locomotion among PD patients, but the effects of non invasive stimulation have never been explored.

Conditions

Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• TUG

  The primary outcome will be the change in gait speed between pre-stimulation and post-stimulation conditions between the two groups (active and placebo) assessed using the 5-meter total Timed Up and Go Test (TUG). Mixel model ANOVA, with TUG as the dependent variable, and time and group as independent variables -'group' would have two levels ('active' and 'placebo'). Our alternative hypothesis is that 'the time vs. group' interaction effect is significant. Then we should use post hoc statistical tests to explore our data further and to compare the effects of active versus placebo at different time levels.

  Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.

Secondary Outcomes (9)

• Secondary outcomes will be the change on other gait measures, gait speed.

  Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.

• Secondary outcomes will be the effects of stimulation on other gait measures, step length, stride length and step width.

  Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.

• Secondary outcomes will be the effects of stimulation on other gait measures, cadencia.

  Baseline, immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.

• Secondary outcomes will be the effects of stimulation on balance after noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.

  Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.

• Determination of possible adverse effects of noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.

  Immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.

Study Arms (2)

ACTIVE

ACTIVE COMPARATOR

In the active group, non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold, this determined by abdominal muscle contractions, found from single pulses, applied gradually every 10 seconds until the contractions appear. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds.

Device: Non-invasive magnetic stimulation of the spinal cord

PLACEBO

PLACEBO COMPARATOR

In the placebo group, a coil will be allocated in the T2-T3 thoracic region, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated. To create a sensation of muscle contraction and impression of active stimulation, both the placebo and active groups will be subjected to the sensory effect of transcutaneous electrical neurostimulation (TENS).

Other: Coil will not be connected to the stimulation device

Interventions

Non-invasive magnetic stimulation of the spinal cord DEVICE

Non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds

Also known as: TMS

ACTIVE

Coil will not be connected to the stimulation device OTHER

coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated

PLACEBO

Eligibility Criteria

• Age: 21 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women (not pregnant) aged between 21 and 80 years old;
• Participants with idiopathic Parkinson's disease in Hoehn Yahr stages between 2 and 4 (moderate disease) during off-medication, whose primary symptom includes change in gait and / or balance (score equal to or greater than 1 in subitem 2.12 of the MSD scale -UPDRS \["gait and balance"\]). The participant must also present freezing (block) of gait (score equal to or greater than 1 in sub-item 2.13 of the MSD-UPDRS scale - "freezing"). Patients should experience the above symptoms even though they are optimized from the medication point of view. The criteria for being optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case. The presence of freezing will be confirmed through a specific scale (FOG score).
• Mini-examination of mental status greater than or equal to 24 points;
• Able to give informed consent in accordance with institutional policies;
• Able to meet all testing and monitoring requirements, as defined by the study protocol;

You may not qualify if:

• Patients with unstabilized psychiatric comorbidities
• Impossibility to consent to your participation in the study.
• Patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease).
• Concomitant treatment with other experimental drugs.
• Pregnant or breastfeeding women.
• Presence of chronic pain in the lower limbs.
• Patients who are unable to walk without assistance (cane, crutch, walker) or help from another person when they are without their medications for Parkinson's disease (off-medication).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubens G Cury, MD

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

Central Study Contacts

Rubens G Cury, MD

CONTACT

5511-26617877; rubens_cury@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The random sequence will be generated by a computer program (randomization.com) using randomly exchanged blocks (size of four per block, active ratio / placebo 1: 1). Randomization will be stratified according to the severity of symptoms (TUG\> 33 seconds = severe group; TUG ≤ 33 seconds = light group). The researchers will be specifically instructed not to break the randomization schedule in any way. Different researchers will carry out randomization, clinical evaluation and stimulation. Patients will be blinded to randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 5, 2021
• Study Start: January 1, 2021
• Primary Completion: September 29, 2021
• Study Completion: January 31, 2022
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)