Priming Theta Burst Stimulation for Stroke: A Study of Intensity

NCT06509789 | Recruiting DMC

• 1 other identifier: HSEARS20240229001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To compare the effects of low intensity priming intermittent theta burst stimulation (iTBS) with those derived from conventional intensity priming iTBS, nonpriming iTBS, and sham stimulation in terms of improving hemiparetic upper limb motor functionality and modulating cortical excitation/inhibition in patients with stroke. Hypothesis to be tested: We hypothesize that low intensity priming iTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in enhanced cortical excitation and reduced cortical inhibition, thereby enabling superior upper limb motor recovery in patients with stroke. Design and subjects: A randomized controlled trial involving 108 patients with chronic stroke. Study instruments: Transcranial magnetic stimulation (TMS) and electroencephalography (EEG). Interventions: Participants will be randomly assigned into one of the following four groups: (1) low intensity priming iTBS (55% resting motor threshold \[RMT\] continuous theta burst stimulation \[cTBS\]+70% RMT iTBS); (2) conventional intensity priming iTBS (70% RMT cTBS+70% RMT iTBS); (3) nonpriming iTBS (sham cTBS+70% RMT iTBS); and (4) sham stimulation (sham cTBS+sham iTBS). All participants will receive 60-minute standard motor training after completion of the stimulation program. The intervention will last four weeks, with three sessions per week. Main outcome measures: Upper limb motor tests and levels of cortical excitation/inhibition measured by TMS-evoked EEG potentials. Data analysis: Analysis of variance (ANOVA). Expected results: The low intensity priming iTBS protocol will be the most efficacious protocol for enhancing cortical excitation and reducing cortical inhibition in post-stroke patients and will thereby produce superior outcomes with regard to upper limb motor functionality.

Conditions

Stroke

Keywords

Stroke; Transcranial magnetic stimulation; Theta burst stimulation

Outcome Measures

Primary Outcomes (3)

• The Fugl-Meyer Assessment-Upper Extremity Scores

  The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb

  Baseline

• The Fugl-Meyer Assessment-Upper Extremity Scores

  The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb

  At 3 weeks

• The Fugl-Meyer Assessment-Upper Extremity Scores

  The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb

  At one-month

Secondary Outcomes (3)

• P30 amplitude in the TMS-evoked potential

  Baseline

• P30 amplitude in the TMS-evoked potential

  At 3 weeks

• P30 amplitude in the TMS-evoked potential

  At one-month

Study Arms (4)

Low intensity priming intermittent theta burst stimulation (iTBS)

EXPERIMENTAL

Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Low intensity priming iTBS consists of a session of 55% RMT cTBS, followed by 70% RMT iTBS.

Device: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol

Standard priming intermittent theta burst stimulation (iTBS)

EXPERIMENTAL

Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Standard priming iTBS consists of a session of 70% RMT cTBS, followed by 70% RMT iTBS.

Device: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol

Nonpriming intermittent theta burst stimulation (iTBS)

ACTIVE COMPARATOR

Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Nonpriming iTBS consists of a session of 20% RMT cTBS (sham), followed by 70% RMT iTBS.

Device: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol

Sham stimulation

SHAM COMPARATOR

Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Sham stimulation consists of a session of 20% RMT cTBS (sham), followed by 20% RMT iTBS (sham).

Device: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol

Interventions

Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol DEVICE

This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.

Low intensity priming intermittent theta burst stimulation (iTBS); Nonpriming intermittent theta burst stimulation (iTBS); Sham stimulation; Standard priming intermittent theta burst stimulation (iTBS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral upper limb motor dysfunction caused by ischemic stroke, with stroke onset≥6 months. Diagnosis will be verified using discharge summary and radiological reports issued by Hospital Authority. Qualifying participants will undergo structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience (UBSN) at PolyU to further confirm their lesion location in the period of experimental participation.
• Age between 18 and 80 years.
• Residual upper limb functions between levels 2-6 in the FTHUE, indicating moderately-to-severely impaired upper limb motor functions.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded:
• any contraindications to TMS (screened by the safety checklist by Rossi(33)) and/or MRI (screened by the MRI safety checklist offered by UBSN \[see supplement\]).
• Diagnosed with any concomitant neurological disease other than stroke.
• signs of cognitive impairment, with a Montreal cognitive assessment score\<21/22 out of 30 (34).
• Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score \> 2 (35).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Tung Wah Hospital: collaborator

Study Sites (1)

Jack Jiaqi Zhang

Hong Kong, Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation; Clinical Protocols

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 24, 2025

Record last verified: 2024-07

Locations

HK (1)