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NCT07833423Not yet recruiting

Efficacy of Temporal Interference-based Deep Brain Stimulation Combined With Conventional Rehabilitation Training for Lower Limb Motor Dysfunction After Stroke

Efficacy of Temporal Interference-based Deep Brain Stimulation Combined With Conventional Rehabilitation Training for Lower Limb Motor Dysfunction After Stroke: A Prospective Randomized Controlled Clinical Trial

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

Stroke, as one of the most disabling neurological diseases worldwide, causes significant functional impairments in the lower limbs, severely affecting the quality of life of patients. Traditional neuroregulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current/alternating current stimulation (tDCS/tACS) can only intervene in the cerebral cortex. Deep brain stimulation (DBS), which requires invasive craniotomy to implant electrodes and has certain risks, is difficult to fully meet the rehabilitation needs of patients. These treatment methods are insufficient. Transcranial Temporal Interference (TI) Stimulation, as a new non-invasive neuroregulation technology, generates low-frequency envelope signals through high-frequency electric fields to achieve precise stimulation of deep brain tissues, providing a new direction for the treatment of stroke. This study is a clinical research to explore the efficacy of TI technology in the treatment of lower limb dysfunction in stroke, aiming to expand the clinical practice of TI technology in the field of stroke rehabilitation and provide theoretical support and practical guidance for the transformation and application of TI technology.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
14 Sept 2026
Start date
1 Oct 2026
Primary completion date
1 Sept 2027
Lead sponsor
The Third People's Hospital of Huizhou
Diseases
Stroke
NCT number
NCT07833423

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Oct 2026 to the primary completion date, 1 Sept 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • People with metallic implants (e.g., aneurysm clips, pacemakers) or skull defects.
  • Hemorrhagic lesions in the basal ganglia (including previous or current basal ganglia hemorrhage).

Other illness

  • Have a history of epilepsy or are taking medications that may lower the seizure threshold.
  • Patients with severe heart, liver, kidney dysfunction or other serious physical diseases.
  • Patients with skin allergy or skin lesions at irritating sites.
  • Impairment of lower limb mobility due to other nonstroke factors was sufficient to significantly affect the primary outcome assessor.

Other

  • Pregnant or lactating women.
  • Inability to cooperate with investigators.
  • At the same time, he participated in other research projects.

Who the study is looking for

  • The patients met the diagnostic criteria of stroke formulated by the Fourth National Cerebrovascular Disease Conference and were confirmed by head CT or MRI.
  • The duration of the first episode ranged from 1 to 6 months.
  • Age ranged from 18 to 75 years and both sexes were included.
  • There was definite lower limb dysfunction, and Brunnstrom stage of lower limbs was II-IV.
  • Informed consent was obtained voluntarily.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.