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Study on the Improvement of Lower Limb Motor Function in Stroke Patients by Time-Domain Interference Stimulation

Analysis of the efficacy and safety of time-domain interference stimulation in treating lower limb dysfunction after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119531
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Stroke

Interventions

Trial Group (Pre-experiment stage):Temporal Interference stimulation (TI): frequency difference between 2000Hz and 2020Hz applied to M1 area, current 2mA, stimulation duration 20min/session, 5 times p
+ conventional rehabilitation therapy: 40min/session, 5 times per week for 2 weeks
Control Group (Pre-experiment stage):Sham Temporal Interference stimulation (TI): simulated using virtual switch without effective stimulation, duration 20min/session, 5 times per week for 2 weeks

Sponsors

Yuebei People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with ischemic or hemorrhagic stroke via CT or MRI; 2. First unilateral lesion accompanied by unilateral lower limb dysfunction; 3. In the subacute phase of stroke, 2 weeks = 24 points, without severe cognitive or communication impairment; 6. No other medications used in addition to routine medication for underlying conditions.

Exclusion criteria

Exclusion criteria: 1. Patients with severe systemic diseases such as cardiovascular or pulmonary conditions who cannot tolerate rehabilitation therapy; 2. Patients diagnosed with severe psychiatric disorders such as major depression; 3. Patients with other neurological diseases besides stroke, such as Parkinson’s disease or epilepsy; 4. Presence of intracranial metal objects or other implanted electronic devices; 5. Use of drugs that alter cortical excitability; 6. Lower limb joint dysfunction or fractures caused by reasons other than stroke; 7. Patients diagnosed with tumors.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment Lower Limb Score;

Secondary

MeasureTime frame
Berg Balance Scale;PC708 Balance Test System (Path Length, Pressure Trajectory Area);Timed Up and Go Test (TUG);Activities of Daily Living (ADL) Index;

Countries

China

Contacts

Public ContactBao Xiao

Yuebei People’s Hospital

baoxiao1981@Sina.com+86 751 6913256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026