Augmented Efficacy of rPMS on the rTMS on Upper Limb Function in Patients With Stroke

NCT05053711 | Unknown DMC

• 1 other identifier: 202002582A3
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, augmented efficacy of rPMS on the rTMS is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: augmented efficacy of rPMS on the rTMS. Several aims in this study include (1) identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), (2 ) establish a novel treatment protocol (augmented efficacy of rPMS on the rTMS), (3) identifying augmented efficacy of rPMS on the rTMS, (4) determining the mechanism of neuro-motor control, and (5) related biomarkers for the novel treatment protocol. The investigators applied a 3-year plan before, however, the Ministry of Science and Technology plan passed one year only (108-2314-B-182-043-). The investigators carried out the pilot study to investigate the augmented effects of rPMS (radial nerve) on the rTMS in the treatment of upper limb function in patients with stroke patients. The previous plan had preliminary results. This year the investigators will apply for a three-year plan to continue the previous pilot study for getting the comprehensive results.

Conditions

Stroke

Keywords

Repetitive transcranial magnetic stimulation; Repetitive peripheral magnetic stimulation; stroke; novel treatment

Outcome Measures

Primary Outcomes (7)

• Change from baseline Motion analysis at after treatment and three month

  All participants will be instructed to perform a series of upper-extremity tasks. The tasks include reaching and grasping. An 7-camera motion analysis system (Vicon system, 3-D Oxfort Metrics Ltd, Oxford, UK) is used in conjunction with a personal computer to capture the movement of markers placed on the participant's body; analog signals were collected simultaneously. Movements were recorded at 120 Hz and digitally low-pass filtered at 5 Hz using a second-order Butterworth filter. Reference markers are placed on the distal interphalangeal joints of the thumb and index finger, the styloid process of the ulna, proximal end of the second metacarpal, and the object.

  baseline, after two weeks of treatment, 3 months

• Change from baseline Motor evoked potential at afte treatment and three month

  The comparison of baseline of Motor Evoked Potential for stroke after different therapy, including resting motor threshold (RMT), active motor thresholds (AMT), input-output curve (IO curve) and stationary period.

  baseline, after two weeks of treatment, 3 months

• Change from baseline Myoton at after treatment and three month

  The comparison of baseline of Myoton for stroke after different therapy, assessing the functional status of skeletal muscle, including tone or state of tension(natural oscillation frequency\[Hz\]), biochanical properties(dynamic stiffness \[N/m\], logarithmic decrement of natural oscillation), viscoelastic properties(mechanical stress relaxation time \[ms\], ratio of deformation and relaxation time, characterising Creep (Deborah number)).

  baseline, after two weeks of treatment, 3 months

• Change from baseline Muscle strength at after treatment and three month

  The comparison of baseline of Muscle strength for stroke after different therapy, including lateral pinch, palmar pinch, and tip pinch, the strength will be tested by hand dynamometer.

  baseline, after two weeks of treatment, 3 months

• Change from baseline Brunnstrom stage at after treatment and three month

  The Brunnstrom stage is used to classify the severity of stroke patient according to specific movement.

  baseline, after two weeks of treatment, 3 months

• Change from baseline Fugl Meyer Assessment at after treatment and three month

  The Fugl Meyer Assessment is used to measure upper and lower extremity motor , range of motion, sensation, pain and balance.

  baseline, after two weeks of treatment, 3 months

• Change from baseline Modified Ashworth Scale at after treatment and three month

  The Modified Ashworth Scale is used to measure the muscle tone of affected limb, for each item minimum value is 0 and maximum value is 4, higher scores mean a worse outcome.

  baseline, after two weeks of treatment, 3 months

Secondary Outcomes (9)

• Change from baseline Action Research Arm Test at after treatment and three month

  baseline, after two weeks of treatment, 3 months

• Change from baseline Box and Block Test at after treatment and three month

  baseline, after two weeks of treatment, 3 months

• Change from baseline Nine-Hole test at after treatment and three month

  baseline, after two weeks of treatment, 3 months

• Change from baseline Jebson Taylor Hand Function Test at after treatment and three month

  baseline, after two weeks of treatment, 3 months

• Change from baseline Functional Independence Measure at after treatment and three month

  baseline, after two weeks of treatment, 3 months

Study Arms (6)

rTMS+rPMS_iTBS_M

EXPERIMENTAL

In this group, they received iTBS on affected hemisphere after following iTBS at median nerve on affected hand.

Device: rTMS+rPMS_iTBS_M

rTMS+rPMS_cTBS_M

EXPERIMENTAL

In this group, they received iTBS on affected hemisphere after following cTBS at median nerve on affected hand.

Device: rTMS+rPMS_cTBS_M

rTMS+sham rPMS_M

SHAM COMPARATOR

In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median nerve on affected hand.

Device: rTMS+sham rPMS_M

rTMS+rPMS_iTBS_U

EXPERIMENTAL

In this group, they received iTBS on affected hemisphere after following iTBS at ulnar nerve on affected hand.

Device: rTMS+rPMS_iTBS_U

rTMS+rPMS_cTBS_U

EXPERIMENTAL

In this group, they received iTBS on affected hemisphere after following cTBS at ulnar nerve on affected hand.

Device: rTMS+rPMS_cTBS_U

rTMS+sham rPMS_U

SHAM COMPARATOR

In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at ulnar nerve on affected hand.

Device: rTMS+sham rPMS_U

Interventions

rTMS+rPMS_iTBS_M DEVICE

Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at median nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).

rTMS+rPMS_iTBS_M

rTMS+rPMS_cTBS_M DEVICE

Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at median nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).

rTMS+rPMS_cTBS_M

rTMS+sham rPMS_M DEVICE

Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at median nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).

rTMS+sham rPMS_M

rTMS+rPMS_iTBS_U DEVICE

Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at ulnaris nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).

rTMS+rPMS_iTBS_U

rTMS+rPMS_cTBS_U DEVICE

Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at ulnar nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).

rTMS+rPMS_cTBS_U

rTMS+sham rPMS_U DEVICE

Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at ulnar nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).

rTMS+sham rPMS_U

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first stoke and in stable phase
• age 20-80 years
• unilateral brain lesions with unilateral hemiplegia
• brain wave examination without epileptic waves

You may not qualify if:

• brain stem or cerebellar stroke
• Patients with epilepsy
• Patients with aneurysm or cerebrovascular malformation
• Patients with mental illness
• Patients with degenerative diseases (such as neurodegenerative diseases)
• Patients with severe intelligence or language barriers (such as mental retardation or severe communication impairment)
• Patients with serious medical conditions (such as heart failure)
• Patients with acute disease (such as infection)
• Patients had metal implants in the body (such as cardiac rhythm or brain metal implants, metal clips for aneurysms)
• Patients had botox injection or surgery in the first half of the study
• Pregnant woman or breastfeeding woman
• other obstacles (such as claustrophobia, obesity, etc.)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memoria Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Chia-Ling Chen

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen, MD, PhD

CONTACT

+886-3-3281200; clingchen@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 22, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 17, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)