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Safety and efficacy of repetitive transcranial magnetic stimulation in post-stroke fatigue intervention

Safety and efficacy of repetitive transcranial magnetic stimulation in post-stroke fatigue intervention

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100784
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Stroke

Interventions

Experimental group 1:conventional training and left DLPFC-repeated Transcranial magnetic stimulation
Experimental group 2:conventional training and affected side-repeated Transcranial magnetic stimulation
Control group:conventional training and left DLPFC-rTMS sham stimulation

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for stroke adopted by the Fourth National Conference on Cerebrovascular Disease and confirmed by cranial CT or MRI, including cerebral infarction, cerebral haemorrhage and cerebral embolism; (2) Aged 18-75 years old, with the first onset of the disease and the duration of the disease within 6 months; (3) Stable vital signs, mRS = 4) on a standardised fatigue rating scale before rTMS treatment; (5) Patients and their families were informed about the study and agreed to participate.

Exclusion criteria

Exclusion criteria: (1) Severe dementia or impaired consciousness, inability to complete scale-related examinations: GCS score <15, MoCA score <19, or cognitive dysfunction as assessed by the MMSE (illiterate <17, primary school group <20, junior high school and above <24); (2) Concomitant with stroke other neurological related diseases or psychiatric related serious diseases (including schizophrenia, severe cognitive impairment, multiple sclerosis, Parkinson's syndrome, traumatic brain injury, epilepsy, cerebral oedema, etc.); (3) Drug use: use of centrally acting drugs that may affect levels of fatigue, depression and anxiety, such as rifampicin, fluoxetine, paroxetine, sertraline, citalopram, fluvoxamine benzodiazepines, hormones and other drugs; (4) Other medical conditions: patients with previous known high prevalence of fatigue, such as tumours, or a combination of other medical conditions or serious illnesses that may interfere with the assessment of fatigue, such as sleep apnoea, episodic somnambulism, hypothyroidism, heart failure, chronic obstructive pulmonary disease; (5) Those with unstable medical conditions and a tendency to deteriorate; (6) Pregnant and lactating women; (7) Contraindications to MRI (e.g. metal foreign bodies in the body) or claustrophobia; (8) Participants who are unwilling or unable to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale, VAS-f;Fatigue Severity Scale, FSS;

Secondary

MeasureTime frame
Brain activation;Emotion;Motor evoked potential;Sleeping;Activities of daily living;Heart rate variation;quality of life;

Countries

China

Contacts

Public ContactYangyun Xuguangxu

The First Affiliated Hospital of Nanjing Medical University

yangyun2066@163.com+86 183 5197 2181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026