Adjunct Low Frequency Repetitive Transcranial Magnetic Stimulation With Physiotherapy Enhance Upper Extremity Function Restoration

NCT02490371 | Completed Results DMC

• 1 other identifier: PT-2015-QEHHK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the leading cause of function disability or impairment. Non-promising functional return from upper limb rehabilitation has been reported. With the technology advances, transcranial magnetic stimulation (TMS), which is a form of non-invasive direct brain stimulation, may act as an attenuator in regulating or modulating the cortical excitability in order to facilitate cortical re-organization and enhance behavioral performance. Various therapeutic exercise protocols have been investigated regarding their efficacy in promoting motor recovery of the affected upper limb for patients after stroke and the preliminary results were supportive. However, limited numbers of randomized control clinical trials have been published in investigating the "priming" or "additive" value of low frequency repetitive TMS (rTMS) with combination of structural motor training programs. Thus the objective of this study is: to determine the effectiveness of the combination of low frequency rTMS on contra-lesional M1 and a structured upper limb motor training program on restoring upper limb function among patients with stroke in sub-acute stage. It is hypothesized that the rTMS, when combined with a structured motor training program, confers additional therapeutic effects on upper limb motor function in subacute stroke patients, when compared with the motor training program alone. The objectives of this study is to determine the effectiveness of the combination of low frequent rTMS on contra-lesional M1 and a structured upper limb motor training program in restoring upper limb function among patients with subacute stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand

  Electromyographic (EMG) activity in first doral interossei measured at 120% resting motor threshold. The motor evoked potential amplitude will be measured peak to peak in millivolt(mV). Higher value mean better control

  Baseline and at 4th weeks and at 12th weeks

Secondary Outcomes (5)

• Change of Upper Limb Impairment From Baseline to at 4th Weeks & 12 th Weeks Training in Fugl-Meyer Assessment (FM) Scale

  Baseline and at 4th weeks and at 12th weeks

• Change of Grip Strength From Baseline to at 4th Weeks and at 12th Weeks Training in Force (Kilogram )

  Baseline and at 4th weeks and at 12th weeks

• Change of Upper Limb Function From Baseline to at 4th Weeks Training in Action Research Arm Test (ARAT) Scale

  Baseline and at 4th weeks and at 12th weeks

• Change of Reaction Time From Baseline to at 4th Weeks and at 12th Weeks Training in Time Measurement (Seconds)

  Baseline and at 4th weeks and at 12th weeks

• Change of Health Status Measurement From Baseline to at 4th Weeks and at 12th Weeks in Stroke Impact Scale

  Baseline and at 4th & 12 th weeks

Study Arms (2)

(1) rTMS- PT Ex Group

EXPERIMENTAL

1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training. After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)

Device: Low frequency rTMS; Behavioral: structured physiotherapy upper limb training

(2) Placebo- PT Ex Group

PLACEBO COMPARATOR

placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training. Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).

Device: Low frequency rTMS; Behavioral: structured physiotherapy upper limb training

Interventions

Low frequency rTMS DEVICE

1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.

(1) rTMS- PT Ex Group; (2) Placebo- PT Ex Group

structured physiotherapy upper limb training BEHAVIORAL

Structural Physiotherapy upper limb training for 30-minutes

(1) rTMS- PT Ex Group; (2) Placebo- PT Ex Group

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever stroke
• Age \>60
• muscle strength \> grade 2 and \< grade 5 based on manual muscle testing of hand / fingers of the affected upper limb
• \> 1 month and \< 6 months after the onset of stroke

You may not qualify if:

• Substantial cognitive impairment with Mini Mental State Test \>24
• Diagnosis of mental illness
• Pathological conditions referred to as contra-indications for rTMS in guideline suggested by Wassermann (eg. Cardiac pacemaker, intracranial implants, implanted medication pumps, epilepsy)
• Unstable cardio-pulmonary conditions -

Sponsors & Collaborators

• Queen Elizabeth Hospital, Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Helen LUK
• Organization: QEHHongKong

clkyz02@ha.org.hk

852-9208 5366

Study Officials

• Ka yan LUK

  Senior Physiotherapist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: July 3, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)