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NCT Number: NCT06415682

The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

Patients in the double-site group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the single-site group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the sham group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 40-80 years;
  • diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
  • patients were stable on dopaminergic treatment for at least 3 months;
  • Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
  • Patients experienced FOG during an interview.

Exclusion criteria

  • comorbidities of major neurologic diseases other than PD;
  • suffer from musculoskeletal disorders that could have interfered with their ability to walk;
  • presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
  • marked tremor interfered with TMS detection;
  • previously receiving any kinds of TMS interventions;
  • severe cognitive impairment making cooperation impossible [Mini Mental State Examination (MMSE) < 24];
  • were unable to walk independently during the OFF state.

Treatment and study plan

SMA+M1 Transcranial Magnetic Stimulation

Device

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration).

Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA).

M1 Transcranial Magnetic Stimulation

Device

The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg.

Sham Transcranial Magnetic Stimulation

Device

Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1 of the lower leg.

Primary outcomes

  1. Changes of Freezing of Gait severity

    Time frame: Assessed at baseline, one day post intervention, one month post intervention

    The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment.

Secondary outcomes

  1. Freezing of Gait severity assessment

    Time frame: Assessed at baseline, one day post intervention, one month post intervention

    The New Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the NFOGQ are 0 and 28. A higher score means a worse outcome. The differences in NFOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment.

  2. Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III)

    Time frame: Assessed at baseline, one day post intervention, one month post intervention

    The measure mainly reflects the overall severity of Parkinson's disease motor symptoms and non-motor symptoms. The minimum value is 0 and the maximum value is 132. A higher score means a worse outcome. The score will be compared to the baseline. The differences in MDS-UPDRS III part scores before and after treatment can be used to evaluate the effect of TMS treatment.

  3. Changes of Gait speed

    Time frame: Assessed at baseline, one day post intervention, one month post intervention

    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. The differences in gait speed before and after treatment can be used to evaluate the effect of TMS treatment.

  4. Changes of Stride length

    Time frame: Assessed at baseline, one day post intervention, one month post intervention

    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. The differences in stride length before and after treatment can be used to evaluate the effect of TMS treatment.

  5. Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF)

    Time frame: Assessed at baseline, one day post intervention

    Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF) are conducted by TMS devices to assess the cortical excitation and inhibition. SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 2ms, 3ms, 4ms interstimulus interval between conditioning and test stimuli. ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 10, 12, 15 ms interstimulus interval between conditioning and test stimuli. For SICF, a subthreshold first stimulus (S1) intensity was set at 1 mV and a subsequent suprathreshold second stimulus (S2) intensity was set at RMT. Interstimulus intervals were 1.0 to 5.0 milliseconds with increments of 0.5 millisecond.The differences in SICI, ICF and SICF before and after treatment can be used to evaluate the effect of TMS treatment.

  6. Changes in functional connectivity in the brain cortex

    Time frame: Assessed at baseline, one day post intervention

    The functional connectivity in the brain cortex will be recorded by functional MRI. The differences in brain regions' functional connectivity before and after treatment can be used to evaluate the effect of TMS treatment.

  7. Changes in brain structure

    Time frame: Assessed at baseline, one day post intervention

    Studying the brain structure among groups. The differences in brain microstructure before and after treatment can be used to evaluate the effect of TMS treatment.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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