N/A
N=24
Adjunct Low Frequency Repetitive Transcranial Magnetic Stimulation With Physiotherapy Enhance Upper Extremity Function Restoration
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02490371 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand — 258.3; 600; 323.3; 565 millivolt
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low frequency rTMS (Device); structured physiotherapy upper limb training (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Queen Elizabeth Hospital, Hong Kong
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand |
258.3; 600; 323.3; 565; 369.1; 586 | — |
| SECONDARY Change of Upper Limb Impairment From Baseline to at 4th Weeks & 12 th Weeks Training in Fugl-Meyer Assessment (FM) Scale |
46.7; 48.8; 52.3; 49.9; 57.0; 53.3 | — |
| SECONDARY Change of Grip Strength From Baseline to at 4th Weeks and at 12th Weeks Training in Force (Kilogram ) |
12.6; 13.8; 13.9; 13.9; 15.4; 14.4 | — |
| SECONDARY Change of Upper Limb Function From Baseline to at 4th Weeks Training in Action Research Arm Test (ARAT) Scale |
36.5; 41.1; 45.4; 41.1; 51.1; 43.2 | — |
| SECONDARY Change of Reaction Time From Baseline to at 4th Weeks and at 12th Weeks Training in Time Measurement (Seconds) |
985.8; 654.2; 902.2; 651.7; 837.3; 637.9 | — |
| SECONDARY Change of Health Status Measurement From Baseline to at 4th Weeks and at 12th Weeks in Stroke Impact Scale |
59; 65.7; 64.1; 69.6; 68.4; 72.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- First-ever stroke
- Age >60
- muscle strength > grade 2 and 1 month and 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 -
Data sourced from ClinicalTrials.gov (NCT02490371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.