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The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
magnetic stimulation
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring freezing of gait, Therapeutics, rTMS, spinal cord stimulation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
  • 2.Item 3 of the New Freezing of Gait Questionnaire(NFOGQ) scored ≥1.
  • 3.Age between 40 and 80 years old.
  • 4.Mini-Mental State Examination score >24.
  • 5.Ability to walk 30 meters independently.
  • 6.Stable medication.

Exclusion Criteria:

  • 1.Other neurological or psychiatric disorders.
  • 2.Severe personality disorder.History of epilepsy, seizures or convulsions.
  • 3.History of head injury or stroke.
  • 4.Metal remains of the skull or inside the brain (outside the oral cavity).
  • 5.Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
  • 6.Severe dyskinesia, termor, cognitive, visual or auditory impairment.
  • 7.Patients who could not complete the follow-up.

Sites / Locations

  • the First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

double active magnetic stimulation

single active magnetic stimulation

double sham magnetic stimulation

Arm Description

the multi-target magnetic stimulation on motor cortex combined with spinal cord

the active magnetic stimulation on motor cortex and sham stimulation on spinal cord

the sham magnetic stimulation on motor cortex and sham stimulation on spinal cord

Outcomes

Primary Outcome Measures

Changes of Freezing of Gait Questionnaire (FOG-Q)
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to the baseline. The minimum and maximum values of the FOG-Q are 0 and 24. A higher FOG-Q score means a worse outcome.

Secondary Outcome Measures

The motor part of the Unified Parkinson's Disease Rating Scale
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. The minimum and maximum values of the motor part of the Unified Parkinson's Disease Rating Scale are 0 and 108. A higher score means a worse outcome.
Gait speed
Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Stride length
Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Stride time variability
Stride time variability (%) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. Stride time variability was expressed as coefficient of variation [CV].
Double support
Double support (%) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Resting motor threshold (RMT)
RMT (% TMS output intensity) is defined as the lowest intensity required to elicit MEPs of > 50 μV in at least 5 of 10 consecutive trials while the target muscle is relaxed. RMT was determined to be the nearest 1% of the maximum stimulator output.
MEP amplitude at 120% RMT intensity (AMP)
Five single stimuli were delivered to the optimal stimulation point at an intensity of 120% of RMT, and the mean peak-to-peak amplitude of the MEPs was calculated, which is the AMP (mV).
Cortical silent period (CSP)
The CSP (ms) is measured through electromyographic signal recording (EMG) on a target muscle and refers to the period of EMG silence following the elicitation of a motor-evoked potential (MEP) through a single TMS pulse delivered over the contralateral primary motor cortex. Individuals were asked to actively contract abductor pollicis brevis (APB) with 20% of the maximum force, while a single pulse with 150% of RMT was applied to the opposite primary motor cortex. We recorded the time from pulse outputting to the recovery of inhibited active contraction as CSP. The above protocol was repeated ten times, and the average value of CSP was calculated.
Short-interval intracortical inhibition (SICI)
SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with a 4ms interstimulus interval between conditioning and test stimuli. Ten trials were acquired for each interstimulus interval. SICI was expressed as the percentage ratio between the test and conditioning MEP.
Intracortical facilitation (ICF)
ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with a 15 ms interstimulus interval between conditioning and test stimuli. Ten trials were acquired for each interstimulus interval. ICF was expressed as the percentage ratio between the test and conditioning MEP.

Full Information

First Posted
November 8, 2021
Last Updated
December 2, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05174299
Brief Title
The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD
Official Title
The Effect of Multi-target Magnetic Stimulation on Freezing Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord will improve FOG and gait symptoms in patients with Parkinson's disease.
Detailed Description
Patients in the Experimental group underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one month post intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
freezing of gait, Therapeutics, rTMS, spinal cord stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
double active magnetic stimulation
Arm Type
Experimental
Arm Description
the multi-target magnetic stimulation on motor cortex combined with spinal cord
Arm Title
single active magnetic stimulation
Arm Type
Active Comparator
Arm Description
the active magnetic stimulation on motor cortex and sham stimulation on spinal cord
Arm Title
double sham magnetic stimulation
Arm Type
Sham Comparator
Arm Description
the sham magnetic stimulation on motor cortex and sham stimulation on spinal cord
Intervention Type
Device
Intervention Name(s)
magnetic stimulation
Intervention Description
For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.
Primary Outcome Measure Information:
Title
Changes of Freezing of Gait Questionnaire (FOG-Q)
Description
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to the baseline. The minimum and maximum values of the FOG-Q are 0 and 24. A higher FOG-Q score means a worse outcome.
Time Frame
Assessed at baseline, one day post intervention, one month post intervention
Secondary Outcome Measure Information:
Title
The motor part of the Unified Parkinson's Disease Rating Scale
Description
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. The minimum and maximum values of the motor part of the Unified Parkinson's Disease Rating Scale are 0 and 108. A higher score means a worse outcome.
Time Frame
Assessed at baseline, one day post intervention, one month post intervention
Title
Gait speed
Description
Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Time Frame
Assessed at baseline, one day post intervention, one month post intervention
Title
Stride length
Description
Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Time Frame
Assessed at baseline, one day post intervention, one month post intervention
Title
Stride time variability
Description
Stride time variability (%) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. Stride time variability was expressed as coefficient of variation [CV].
Time Frame
Assessed at baseline, one day post intervention, one month post intervention
Title
Double support
Description
Double support (%) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Time Frame
Assessed at baseline, one day post intervention, one month post intervention
Title
Resting motor threshold (RMT)
Description
RMT (% TMS output intensity) is defined as the lowest intensity required to elicit MEPs of > 50 μV in at least 5 of 10 consecutive trials while the target muscle is relaxed. RMT was determined to be the nearest 1% of the maximum stimulator output.
Time Frame
Assessed at baseline, one day post intervention.
Title
MEP amplitude at 120% RMT intensity (AMP)
Description
Five single stimuli were delivered to the optimal stimulation point at an intensity of 120% of RMT, and the mean peak-to-peak amplitude of the MEPs was calculated, which is the AMP (mV).
Time Frame
Assessed at baseline, one day post intervention.
Title
Cortical silent period (CSP)
Description
The CSP (ms) is measured through electromyographic signal recording (EMG) on a target muscle and refers to the period of EMG silence following the elicitation of a motor-evoked potential (MEP) through a single TMS pulse delivered over the contralateral primary motor cortex. Individuals were asked to actively contract abductor pollicis brevis (APB) with 20% of the maximum force, while a single pulse with 150% of RMT was applied to the opposite primary motor cortex. We recorded the time from pulse outputting to the recovery of inhibited active contraction as CSP. The above protocol was repeated ten times, and the average value of CSP was calculated.
Time Frame
Assessed at baseline, one day post intervention.
Title
Short-interval intracortical inhibition (SICI)
Description
SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with a 4ms interstimulus interval between conditioning and test stimuli. Ten trials were acquired for each interstimulus interval. SICI was expressed as the percentage ratio between the test and conditioning MEP.
Time Frame
Assessed at baseline, one day post intervention.
Title
Intracortical facilitation (ICF)
Description
ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with a 15 ms interstimulus interval between conditioning and test stimuli. Ten trials were acquired for each interstimulus interval. ICF was expressed as the percentage ratio between the test and conditioning MEP.
Time Frame
Assessed at baseline, one day post intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist. 2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1. 3.Age between 40 and 80 years old. 4.Mini-Mental State Examination score >24. 5.Ability to walk 30 meters independently. 6.Stable medication. 7.Patients experienced FOG in both medication "on" and "off" states. Exclusion Criteria: 1.Other neurological or psychiatric disorders. 2.Severe personality disorder.History of epilepsy, seizures, or convulsions. 3.History of head injury or stroke. 4.Metal remains of the skull or inside the brain (outside the oral cavity). 5.Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps. 6.Severe dyskinesia, termor, cognitive, visual or auditory impairment. 7.Patients who could not complete the follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kezhong Zhang
Phone
13770840575
Email
kezhong_zhang1969@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kezhong Zhang
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiang Su
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kezhong Zhang
Phone
13770840575
Email
kezhong_zhang1969@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD

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