Dual-target, High-dose TMS for PD Patients With FOG

NCT05625386 | Terminated

• 1 other identifier: AHMU-TMS-FOG-twotargets
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study was to verify whether high-dose TMS treatment of the motor and cognitive cortices is more effective in alleviating FOG than conventional-dose TMS of the motor cortex only. Specifically, investigator hypothesized that the effect of dual-target TMS on FOG is better than traditional stimulation of the motor cortex only, and the effect of high-dose TMS is better than conventional doses.

Conditions

Transcranial Magnetic Stimulation; Freezing of Gait

Keywords

Transcranial Magnetic Stimulation; Freezing of Gait

Outcome Measures

Primary Outcomes (1)

• The Freezing of Gait Questionnaire (FOGQ) scores

  This is an very common clinical motor estimating scale for evaluating FOG. 6 items and each item scored between 0 and 4 points (24 scores in total). Higher scores mean a worse outcome

  the changes in FOGQ scores from baseline to 1 month after completion of TMS (follow-up).

Secondary Outcomes (5)

• The timed up and go test (TUG)

  changes from baseline to 1 month after completion of TMS (follow-up).

• Unified Parkinson's Disease Rating Scale III (UPDRSIII) scores

  changes from baseline to 1 month after completion of TMS (follow-up).

• Stroop test

  changes (SCN, SWR, SCW) from baseline to 1 month after completion of TMS (follow-up).

• Color Trails Test interference index (CTTII)

  changes rom baseline to 1 month after completion of TMS (follow-up).

• The Standing-Start 180° Turn Test (SS-180)

  changes from baseline to 1 month after completion of TMS (follow-up).

Study Arms (3)

Dual-target high-dose TMS (DHT)

EXPERIMENTAL

DHT refers to the left primary motor cortex of the lower leg (M1) and dorsolateral prefrontal cortex (DLPFC) receiving 9000 pulses/day of intermittent TBS (iTBS) for 5 consecutive days. Each iTBS sequence in the high-dose stimulation sequence released 900 pulses at a time with a pulse cluster repeated every 200 ms at a frequency of 5 Hz. Each pulse cluster contained three pulses with a frequency of 50 Hz, stimulation time of 2 s, and interval of 8 s. A total of 10 iTBS sessions was performed each day with an interval of 40 min and the daily stimulation dose was 9000 pulses. The order of stimulation for the two targets was randomized across participants and the order of stimulation within participants remained unchanged throughout the session.

Device: transcranial magnetic stimulation

Dual-target conventional-dose TMS (DCT)

EXPERIMENTAL

DCT refers to the left M1 and DLPFC receiving 1800 pulses/day of iTBS for 5 consecutive days. Each iTBS sequence in the conventional-dose stimulation sequence released 600 pulses at a time with a pulse cluster repeated every 200 ms at a frequency of 5 Hz. Each pulse cluster contained three pulses with a frequency of 50 Hz, stimulation time of 2 s, and interval of 8 s. A total of three iTBS sessions were performed each day with an interval of 40 min and the daily stimulation dose was 1800 pulses.The order of stimulation for the two targets was randomized across participants and the order of stimulation within participants remained unchanged throughout the session.

Device: transcranial magnetic stimulation

Single-target conventional-dose TMS (SCT)

ACTIVE COMPARATOR

SCT refers to the left M1 receiving 1800 pulses/day of iTBS treatment for 5 consecutive days. Each iTBS sequence in the conventional-dose stimulation sequence released 600 pulses at a time with a pulse cluster repeated every 200 ms at a frequency of 5 Hz. Each pulse cluster contained three pulses with a frequency of 50 Hz, stimulation time of 2 s, and interval of 8 s. A total of three iTBS sessions were performed each day with an interval of 40 min and the daily stimulation dose was 1800 pulses.

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

TMS was performed using a Magstim Rapid2 transcranial magnetic stimulator (Magstim Company, Whitland, UK) with a 70-mm air-cooled figure-of-eight coil. All stimulations were guided by a frameless neuronavigation system (Brainsight; Rogue Research, Montreal, QC, Canada).

Dual-target conventional-dose TMS (DCT); Dual-target high-dose TMS (DHT); Single-target conventional-dose TMS (SCT)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of FOG with expertise in movement disorders.
• the score of item 3 of the FOG questionnaire ≥1.
• ongoing treatment with a stable dose of any medication for 2 months.
• years of age or older.

You may not qualify if:

• a history of addiction, psychiatric disorders, or neurological diseases other than PD.
• focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
• anti-PD medication adjustments during rTMS treatment.
• history of substance abuse within the past 6 months.
• nonremovable metal objects in or around the head.
• previously received rTMS treatment.
• prior history of seizure or history in first-degree relatives.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Kai Wang, Ph.D.

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: November 22, 2022
• Study Start: December 22, 2022
• Primary Completion: February 25, 2024
• Study Completion: March 31, 2024
• Last Updated: November 19, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)