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Improvement of speech function in patients with aphasia after stroke after transection of the seventh cervical nerve: an exploratory randomized controlled clinical trial

Improvement of speech function in patients with aphasia after stroke after transection of the seventh cervical nerve: a multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057180
Enrollment
Unknown
Registered
2022-03-02
Start date
2022-07-25
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Aphasia after stroke

Interventions

Group A:Neurotomy of C7 nerve at intervertebral foramen and intensive speech and language therapy
Group B:Intensive speech and language therapy

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Magnetic resonance imaging confirmed left hemisphere cerebral infarction/hemorrhage, aphasia after single onset, onset more than 12 months; 2. Aged 40-65 years, right-handed, native Chinese, no gender limit; 3. The aphasia quotient of WAB score was less than 93.8; 4. BDAE severity level 1 or above; 5. Strong compliance, can cooperate with language rehabilitation training; 6. Be able to fully understand and agree with the doctor's treatment plan, and sign the informed consent. The third and fourth points should be diagnosed by two attending or above specialists respectively.

Exclusion criteria

Exclusion criteria: 1. Contraindications of surgery for any reason as judged by a qualified anesthesiologist or clinician; 2. Patients with aphasia history before the onset of stroke; 3. Severe, untreated mental illness; 4. Aphasia due to degenerative neurological diseases or brain trauma; 5. Contraindications of EEG and MRI; 6. Inability to complete the assessments and rehabilitation required per study design; 7. Severe motor speech disorder and hearing impairment; 8. Received intensive post-stroke rehabilitation therapy 4 weeks before enrollment.

Design outcomes

Primary

MeasureTime frame
Change of Boston Naming Test Score;

Secondary

MeasureTime frame
Change in ICF Speech and Language Function Assessment Score;Changes of Western Aphasia Battery Score;Changes of Activity of Daily Living Scale, ADL;Changes of Communication Activity of Daily Living Scale;Change in post-stroke Depression Scale/Hamilton Depression Scale;

Countries

China

Contacts

Public ContactXu Wendong

Huashan Hospital, Fudan University

wendongxu@fudan.edu.cn+86 21 5288 8733

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026