Efficacy of Integrated Therapy of rTMS and rPMS on Upper Limb Function in Patients With Stroke

NCT04265365 | Unknown DMC

• 1 other identifier: 201802219A3
• Study Type: interventional
• Target: 90
• 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, the integrated therapy of rTMS and with repetitive peripheral magnetic stimulaiton (rPMS) is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: rTMS integrated with rPMS.

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 six weeks of 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 6 weeks of treatment, 3 months

• Change from baseline Motor evoked potential at after six weeks of 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 6 weeks of treatment, 3 months

• Change from baseline Myoton at after six weeks of treatment and three month

  The comparison of baseline of Myoton for stroke after different therapy, assessing the functional status of skeletal muscle.

  baseline, after 6 weeks of treatment, 3 months

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

  The comparison of baseline of Muscle strength for stroke after different therapy, including lateral pinch, palmar pinch, and tip pinch.

  baseline, after 6 weeks of treatment, 3 months

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

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

  baseline, after 6 weeks of treatment, 3 months

• Change from baseline Fugl Meyer Assessment at after six weeks of 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 6 weeks of treatment, 3 months

• Change from baseline Modified Ashworth Scale at after six weeks of 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 6 weeks of treatment, 3 months

Secondary Outcomes (9)

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

Study Arms (9)

rTMS+rPMS_iTBS_R

EXPERIMENTAL

In this group, they received intermittent theta burst stimulation(iTBS) on affected hemisphere after following iTBS at radial nerve on affected hand.

Device: rTMS+rPMS_iTBS_R

rTMS+rPMS_cTBS_R

EXPERIMENTAL

In this group, they received intermittent theta burst stimulation on affected hemisphere after following continuous theta burst stimulation(cTBS) at radial nerve on affected hand.

Device: rTMS+rPMS_cTBS_R

rTMS +sham-rPMS

SHAM COMPARATOR

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

Device: rTMS +sham-rPMS

rTMS+rPMS_iTBS_M/U

EXPERIMENTAL

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

Device: rTMS+rPMS_iTBS_M/U

rTMS+rPMS_cTBS_M/U

EXPERIMENTAL

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

Device: rTMS+rPMS_cTBS_M/U

sham-rTMS+sham-rPMS

SHAM COMPARATOR

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

Device: sham-rTMS+sham-rPMS

rTMS + optimal-rPMS

EXPERIMENTAL

In this group, patient received iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation(rPMS) on affected hand.

Device: rTMS + optimal-rPMS

rTMS+ sham-rPMS

EXPERIMENTAL

In this group, patient received iTBS on affected hemisphere after following sham repetitive peripheral magnetic stimulation on affected hand.

Device: rTMS +sham-rPMS

sham-rTMS+optimal-rPMS

SHAM COMPARATOR

In this group, patient received sham iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation on affected hand.

Device: sham-rTMS+optimal-rPMS

Interventions

rTMS+rPMS_iTBS_R 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 radial 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_R

rTMS+rPMS_cTBS_R 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 radial 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_R

rTMS +sham-rPMS 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 radial nerve on the affected hand(almost no 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 +sham-rPMS; rTMS+ sham-rPMS

rTMS+rPMS_iTBS_M/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 median nerve/nervus ulnaris 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/U

rTMS+rPMS_cTBS_M/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 median nerve/nervus ulnaris 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/U

sham-rTMS+sham-rPMS 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/nervus ulnaris 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).

sham-rTMS+sham-rPMS

rTMS + optimal-rPMS DEVICE

The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. 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 + optimal-rPMS

sham-rTMS+optimal-rPMS DEVICE

The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. 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).

sham-rTMS+optimal-rPMS

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

Study Sites (1)

Chang Gung Memoria Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (1)

• Chang CS, Chen CL, Chen RS, Chen HC, Chen CY, Chung CY, Wu KP, Wu CY, Lin KC. Synergistic efficacy of repetitive peripheral magnetic stimulation on central intermittent theta burst stimulation for upper limb function in patients with stroke: a double-blinded, randomized controlled trial. J Neuroeng Rehabil. 2024 Apr 8;21(1):49. doi: 10.1186/s12984-024-01341-w.

  PMID: 38589875 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

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

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: February 2, 2020
• First Posted: February 11, 2020
• Study Start: February 27, 2019
• Primary Completion: December 11, 2022
• Study Completion: February 11, 2023
• Last Updated: March 9, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)