High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: HD-tCES; Device: Sham HD-tCES; Other: Lower limb rehabilitation

• Registration Number: NCT04515121
• Lead Sponsor: Taipei Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-17
• Study Start: 2020-08-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. With a diagnosis of stroke.
2. Age ≥ 20 years.
3. Hemiplegia, Brunnstrom stage III-V.
4. 6 months to 5 years after stroke.
5. Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
6. 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

1. Intolerance to electrical stimulation.
2. Contracture on lower extremities, and limitation in joint range of motion.
3. Severe spasticity.
4. Ossification or inflammation in muscle tissue.
5. A history of arrhythmia.
6. Implantable medical electronic devices (e.g., like pacemaker).
7. Metal implants in the head or neck.
8. Wounds on the skin of head.
9. A history of brain surgery or severe brain trauma.
10. Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
11. A history of seizure or other brain pathology.
12. Drug or alcohol abuse.
13. Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
14. Undergoing other non-invasive brain stimulation.
15. Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
16. History of encephalitis or meningitis.
17. Stroke lesion in cerebellum or brainstem.
18. Leg amputation.
19. Sleep deprivation.
20. Severe or recent heart disease.
21. Subjects who use drugs that may lower the seizure threshold.
22. Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham HD-tCES & lower limb rehabilitation	Lower limb rehabilitation	The sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side.
HD-tCES & lower limb rehabilitation	HD-tCES	The experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side.
HD-tCES & lower limb rehabilitation	Lower limb rehabilitation	The experiment group will receive HD-tCES combined with lower limb rehabilitation of affected side.
Sham HD-tCES & lower limb rehabilitation	Sham HD-tCES	The sham control group will receive sham HD-tCES combined with lower limb rehabilitation of affected side.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Fugl-Meyer Assessment lower extremity scale (FMA-LE) after intervention	Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)	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

Name	Time	Method
Change from baseline in the Timed Up and Go Test (TUG) after intervention	Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)	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	Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)	The Gait Evaluation includes cadence, stride duration, stride length, and velocity.
Change from baseline in the Modified Ashworth Scale (MAS) after intervention	Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)	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.
Incidence of treatment-emergent adverse events	Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks)	Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Change from baseline motor evoked potential (MEP) after intervention	Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)	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.
Change from baseline in the Berg Balance Scale (BBS) after intervention	Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)	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.

Trial Locations

Locations (3)

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare; 🇨🇳 New Taipei City, Taiwan

Taipei Municipal Wanfang Hospital - Taipei Medical University; 🇨🇳 Taipei, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan