High-definition electrical stimulation for rehabilitation after stroke

Neural Mechanisms and Augmented Efficacy of High-definition Transcranial Electrical Stimulation on Upper-extremity Function in Patients With Subacute Stroke

This study is testing if a new type of electrical stimulation can help stroke patients recover better use of their arms during rehabilitation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 3 sites (New Taipei City and 2 other locations)
• Trial ID: NCT06409143 on ClinicalTrials.gov

What this trial studies

This project investigates the effects of high-definition transcranial electrical stimulation (HD-tES) on upper limb rehabilitation in stroke patients. It includes two sub-projects: one assessing various stimulation waveforms on healthy adults to determine optimal neuromodulatory effects, and another exploring the impact of unilateral and bilateral HD-tES combined with conventional rehabilitation in patients with subacute stroke. The study aims to enhance brain activity in affected areas while modulating activity in unaffected regions, with careful monitoring of cortical excitability changes. The approach utilizes advanced electrode configurations for targeted stimulation, diverging from traditional methods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and above with unilateral hemiparesis due to stroke, either in the subacute phase (7 days to 6 months post-stroke) or chronic phase (more than 6 months post-stroke).

Not a fit: Patients with severe muscle spasticity or those with a history of neurological or psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve upper limb function and quality of life for stroke patients.

How similar studies have performed: Other studies have shown promise with similar neuromodulatory approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

\- Sub-Project 1 (Healthy)

1. Adults aged 18 and above.
2. Confirmed right-handedness using the Edinburgh Handedness Inventory.

Sub-Project 1 (Post-stroke patients)

1. Aged 18 and above.
2. Diagnosed with stroke.
3. Post-stroke for more than 6 months.
4. Unilateral hemiparesis.

Sub-Project 2 (Subacute-stroke patients)

1. Aged 18 and above.
2. Diagnosed with stroke.
3. Stroke occurred between 7 days to 6 months ago.
4. Unilateral hemiparesis.
5. Degree of recovery for proximal and distal movements of the affected upper limb is Brunnstrom stage III to V.
6. No severe muscle spasticity in any segments of the affected upper limb (Modified Ashworth Scale ≤ 2).

Exclusion Criteria:

\- Sub-Project 1 (Healthy)

1. History of neurological disorders (e.g., stroke, brain tumor, epilepsy), psychiatric disorders (e.g., substance abuse, major depression, schizophrenia, bipolar disorder), or musculoskeletal disorders of the upper limb.
2. Contraindications to transcranial electrical stimulation, including history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
3. Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
4. Participation in other invasive or non-invasive brain stimulation research studies.
5. Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
6. History of alcohol or substance abuse.
7. Damaged skin at the stimulation site, electrode contact, or device wearing site.
8. Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold.
9. Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician.
10. Affiliation with any research institution/execution unit (e.g., students from NTU, Taipei Medical University).

Sub-Project 1 (Post-stroke patients)

1. Contraindications to transcranial electrical stimulation include a history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
2. Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
3. Severe neurological or psychiatric disorders other than stroke (such as major depression, schizophrenia, substance abuse, organic brain diseases, Parkinson's disease, brain tumors).
4. Use of medications that may lower the seizure threshold.
5. Undergoing other invasive or non-invasive brain stimulation therapies.
6. Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
7. History of alcohol or substance abuse.
8. Damaged skin at the stimulation site, electrode contact, or device wearing site.
9. Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold.
10. Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician.

Sub-Project 2 (Subacute-stroke patients)

1. Contraindications to transcranial electrical stimulation include a history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure.
2. Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head.
3. Severe neurological or psychiatric disorders other than stroke (such as major depression, schizophrenia, substance abuse, organic brain diseases, Parkinson's disease, brain tumors).
4. Use of medications that may lower the seizure threshold.
5. Other muscle and joint problems affecting upper limb function, such as joint contractures, rheumatoid arthritis, myositis ossificans.
6. Severe cognitive impairment or receptive or global aphasia making it difficult to understand instructions.
7. Hemineglect (including visual, auditory, or sensory neglect).
8. Undergoing other invasive or non-invasive brain stimulation therapies.
9. Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
10. History of alcohol or substance abuse.
11. Damaged skin at the stimulation site, electrode contact, or device wearing site.
12. Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold.
13. Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician.

Where this trial is running

New Taipei City and 2 other locations

• New Taipei City Tucheng Hospital — New Taipei City, Taiwan (Not_yet_recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
• Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Mon-Ting Lin

Conditions Stroke; High-Definition Transcranial Electrical Stimulation; Upper-limb rehabilitation; Transcranial electrical stimulation; Neuroplasticity