Back to resultsHigh-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HD-tCES
Sham HD-tCES
Lower limb rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Transcranial electrical stimulation, Lower-limb rehabilitation
Eligibility Criteria
Inclusion Criteria:
- With a diagnosis of stroke.
- Age ≥ 20 years.
- Hemiplegia, Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
- Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance.
Exclusion Criteria:
- Intolerance to electrical stimulation.
- Contracture on lower extremities, and limitation in joint range of motion.
- Severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of arrhythmia.
- Implantable medical electronic devices (e.g., like pacemaker).
- Metal implants in the head or neck.
- Wounds on the skin of head.
- A history of brain surgery or severe brain trauma.
- Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
- A history of seizure or other brain pathology.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
- Undergoing other non-invasive brain stimulation.
- Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
- History of encephalitis or meningitis.
- Stroke lesion in cerebellum or brainstem.
- Leg amputation.
- Sleep deprivation.
- Severe or recent heart disease.
- Subjects who use drugs that may lower the seizure threshold.
- Pregnant or breastfeeding women.
Sites / Locations
- Taipei Medical University-Shuang Ho Hospital,Ministry of Health and WelfareRecruiting
- Taipei Medical University HospitalRecruiting
- Taipei Municipal Wanfang Hospital - Taipei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
HD-tCES & lower limb rehabilitation
Sham HD-tCES & lower limb rehabilitation
Arm Description
The experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side.
The sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side.
Outcomes
Primary Outcome Measures
Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention
The FMA-LE assesses motor functioning of lower extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-LE is 34, and a higher score indicates that the patient has better movement ability.
Secondary Outcome Measures
Change from baseline in the Berg Balance Scale (BBS) after intervention
The BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It contains 14 items with each item consisting of a five-point ordinal scale ranging from 0 to 4. A higher score indicates that the patient has better balance.
Change from baseline in the Timed Up and Go Test (TUG) after intervention
The TUG assesses a patient's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Change from baseline in the Gait Evaluation after intervention
The Gait Evaluation includes cadence, stride duration, stride length, and velocity.
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
The MAS is commonly used in clinical practice for grading spasticity. The MAS is rated on a 6-point scale (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension. The muscles being assessed include hip flexor, hip extensor, knee flexor, knee extensor, ankle dorsiflexor, and ankle plantarflexor.
Change from baseline motor evoked potential (MEP) after intervention
The MEP elicited in peripheral muscles by transcranial magnetic stimulation over motor cortex is one of the hallmark measures for non-invasive quantification of cortical excitability.
Incidence of treatment-emergent adverse events
Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Full Information
NCT ID
NCT04515121
First Posted
August 13, 2020
Last Updated
January 28, 2023
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04515121
Brief Title
High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation
Official Title
Effects of High-definition Transcranial Electrical Stimulation on the Lower Extremity in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. We developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, we will preliminarily examine the effects and safety of the HD-tCES on lower extremity in patients with stroke. We expect that the HD-tCES combined with the lower extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Transcranial electrical stimulation, Lower-limb rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HD-tCES & lower limb rehabilitation
Arm Type
Experimental
Arm Description
The experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side.
Arm Title
Sham HD-tCES & lower limb rehabilitation
Arm Type
Sham Comparator
Arm Description
The sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side.
Intervention Type
Device
Intervention Name(s)
HD-tCES
Intervention Description
The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Sham HD-tCES
Intervention Description
The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
Intervention Type
Other
Intervention Name(s)
Lower limb rehabilitation
Intervention Description
Lower limb rehabilitation programs will be selected and graded in accordance with each patient's lower limb function and specific aims of activities of daily living. Lower limb rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention
Description
The FMA-LE assesses motor functioning of lower extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-LE is 34, and a higher score indicates that the patient has better movement ability.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Secondary Outcome Measure Information:
Title
Change from baseline in the Berg Balance Scale (BBS) after intervention
Description
The BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It contains 14 items with each item consisting of a five-point ordinal scale ranging from 0 to 4. A higher score indicates that the patient has better balance.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline in the Timed Up and Go Test (TUG) after intervention
Description
The TUG assesses a patient's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline in the Gait Evaluation after intervention
Description
The Gait Evaluation includes cadence, stride duration, stride length, and velocity.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline in the Modified Ashworth Scale (MAS) after intervention
Description
The MAS is commonly used in clinical practice for grading spasticity. The MAS is rated on a 6-point scale (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension. The muscles being assessed include hip flexor, hip extensor, knee flexor, knee extensor, ankle dorsiflexor, and ankle plantarflexor.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Change from baseline motor evoked potential (MEP) after intervention
Description
The MEP elicited in peripheral muscles by transcranial magnetic stimulation over motor cortex is one of the hallmark measures for non-invasive quantification of cortical excitability.
Time Frame
Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
Title
Incidence of treatment-emergent adverse events
Description
Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Time Frame
Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With a diagnosis of stroke.
Age ≥ 20 years.
Hemiplegia, Brunnstrom stage III-V.
6 months to 5 years after stroke.
Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance.
Exclusion Criteria:
Intolerance to electrical stimulation.
Contracture on lower extremities, and limitation in joint range of motion.
Severe spasticity.
Ossification or inflammation in muscle tissue.
A history of arrhythmia.
Implantable medical electronic devices (e.g., like pacemaker).
Metal implants in the head or neck.
Wounds on the skin of head.
A history of brain surgery or severe brain trauma.
Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
A history of seizure or other brain pathology.
Drug or alcohol abuse.
Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
Undergoing other non-invasive brain stimulation.
Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
History of encephalitis or meningitis.
Stroke lesion in cerebellum or brainstem.
Leg amputation.
Sleep deprivation.
Severe or recent heart disease.
Subjects who use drugs that may lower the seizure threshold.
Pregnant or breastfeeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Hung Lai, PhD
Phone
+886-2-27372181
Ext
1236
Email
chlai@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Chou Chen, MD
Phone
+886-970-747-158
Email
b8601084@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Hung-Chou Chen, MD
First Name & Middle Initial & Last Name & Degree
Shih-Wei Huang, PhD
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, PhD
Phone
+886-2-27372181
Ext
1236
Email
chlai@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, PhD
Facility Name
Taipei Municipal Wanfang Hospital - Taipei Medical University
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang-Hwa Chang, MS
Phone
+886-970-746-881
Email
chang2773@gmail.com
First Name & Middle Initial & Last Name & Degree
Kwang-Hwa Chang, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation
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