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

Parkinson Disease Clinical Trial

Official title:

The Effect of Multi-target Magnetic Stimulation on Freezing Gait in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174299
• Other study ID #: 2021-SR-209
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Kezhong Zhang
• Phone: 13770840575
• Email: kezhong_zhang1969[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• magnetic stimulation
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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiang Su

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at baseline, one day post intervention, one month post intervention
Secondary	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.	Assessed at baseline, one day post intervention, one month post intervention
Secondary	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.	Assessed at baseline, one day post intervention, one month post intervention
Secondary	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.	Assessed at baseline, one day post intervention, one month post intervention
Secondary	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].	Assessed at baseline, one day post intervention, one month post intervention
Secondary	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.	Assessed at baseline, one day post intervention, one month post intervention
Secondary	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.	Assessed at baseline, one day post intervention.
Secondary	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).	Assessed at baseline, one day post intervention.
Secondary	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.	Assessed at baseline, one day post intervention.
Secondary	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.	Assessed at baseline, one day post intervention.
Secondary	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.	Assessed at baseline, one day post intervention.