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A pilot trial to evaluate the effectiveness and safety of scalp acupuncture and electro-magnetic convergence stimulation in patient with cerebral infarction

A randomized controlled pilot trial to evaluate the effectiveness and safety of scalp acupuncture and electro-magnetic(SAEM) convergence stimulation in patient with first-ever cerebral infarction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001768
Enrollment
60
Registered
2016-01-14
Start date
2015-07-29
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Participants with motion or sensory disability caused by a first-time cerebral infarction (n = 60) that had occurred within 1 month of the study onset were randomly

Sponsors

Dongshin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who met all of the following conditions were considered for enrollment. Patients who were > 19-years-old; had incipient CI confirmed by a computed tomography or magnetic resonance imaging examination and who were diagnosed by a neurologist or neurosurgeon; experienced a CI that had occurred within 1 month of the study onset, and resulted in motor and sensory disorders; could undergo rehabilitation therapy after hospitalization in the Department of Physical and Rehabilitation Medicine, Chonnam National University Hospital; had a modified Rankin Scale (mRS) score of 2–4; had sufficient cognitive function level and voluntarily signed an informed consent form.

Exclusion criteria

Exclusion criteria: Subjects whose general condition was not good or fit for SA and rTMS therapies were excluded. Additional exclusion criteria were as follows : history of brain lesion (e.g., stroke, serious mental illness, loss of consciousness accompanied by head trauma, brain surgery, or seizure disorder); presence of other serious illnesses (e.g., cancer, Alzheimer's disease, epilepsy, head trauma, or cerebral palsy); transient ischemic attacks (TIA); contraindications to electromagnetic stimulation (e.g., metal implants in the brain, implanted electronic devices in the body, such as non- detachable ferromagnetic metals, metal sensitive implants less than 30-cm away from the brain like cochlear implants, pacemakers, aneurysm clips or coils, stents, bullet fragments, deep brain stimulation, vagus nerve stimulators, jewelry, or hairpins); continuous convulsion symptoms; previous craniectomy or shunt surgery; elevated intracranial pressure symptoms such as headache, vomiting, nausea, etc.; seizure disorder or epilepsy after cerebral infarction; history of stroke accompanied by a clear clinical sign; contraindications to SA (e.g., scalp scarring, inflammation from scalp injury or infection in the treatment region, inability to stop blood flow due to blood clotting disturbances, such as hemophilia etc., serious unusual response after acupuncture treatment); women who were pregnant or breast feeding; patients who were inmates at group facilities such as social welfare institutions; patients who disagreed with the informed consent; and individuals scheduled for surgery within 2 weeks.

Design outcomes

Primary

MeasureTime frame
Fugl-Mayer Assessment(FMA)

Secondary

MeasureTime frame
National Institute of Health Stroke Scale(NIHSS);Modified Barthel Index(MBI);Functional Independent Measurement(FIM);Korean-Mini Mental State Examination(K-MMSE);American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale(ASHA-NOMS);Functional Ambulatory Category(FAC);modified Rankin Scale(mRS); European Quality of Life-5 Dimensions(EQ-5D);Modified Asworth Scale(MAS);Hand Grip Strength Test;9-hole Peg Board Test;Motor Evoked Potential(MEP)

Countries

Korea, Republic of

Contacts

Public ContactJae-Hong Kim

Dongshin University

nahonga@hanmail.net+82-62-350-7209

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 1, 2026