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Study on the Effects of Closed-Loop Theory-Based Synergistic Regulation of Repetitive rTMS and rPNMS on Consciousness and Evoked Potentials in Patients with Prolonged Disorders of Consciousness after Cerebral Hemorrhage

Study on the Effects of Closed-Loop Theory-Based Synergistic Regulation of Repetitive rTMS and rPNMS on Consciousness and Evoked Potentials in Patients with Prolonged Disorders of Consciousness after Cerebral Hemorrhage

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106064
Enrollment
Unknown
Registered
2025-07-16
Start date
2024-10-08
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Cerebral hemorrhage

Interventions

rPNMS+rTMS group:rPNMS+rTMS
rPNMS+ sham rTMS group:rPNMS+ sham rTMS
sham rPNMS+rTMS:sham rPNMS+rTMS

Sponsors

Guangdong Sanjiu Brain Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic consciousness disorder caused by intracerebral hemorrhage, the diagnosis conforms to the Chinese Expert Consensus on the Diagnosis and Treatment of Chronic Consciousness Disorder (Chinese Journal of Neurology, 2020) of the Chinese Medical Doctor Association; 2. Diagnosis of VS or MCS according to the Revised Coma Recovery Scale (CRS-R); 3. The course of the disease is 3~6 months, the first onset of the disease and the clinical symptoms are stable; 4. No obvious cerebral edema and no severe cerebral atrophy; 5. 18 years old< = age< = 70 years; 6. No skull defect, no infection, no bleeding point, no damage at the stimulation site; 7. The legal guardian agrees and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with unclear diagnosis in pre-screening assessment and fluctuating diagnosis in baseline assessment; 2. Presence of contraindications to treatment such as pacemaker, skull repair surgery, metal brain implant or nerve stimulator; 3. Patients taking sedative medications and Na or Ca2 channel blockers or NMDA receptor antagonists to avoid interactions with the putative neuromodulatory effects of rTMS; 4. Those who are undergoing neuromodulation therapy such as TMS and vagus nerve stimulation; 5. History of epilepsy, psychiatric disease, neurodegenerative disease or drug abuse and alcoholism; 6. Other diseases that cause consciousness disorders, such as severe acute infection, endocrine and metabolic disorders, cerebral mass diseases, and water and electrolyte balance disorders; 7. Patients with a tendency to recurrent intracerebral hemorrhage; 8. There are factors that affect the alteration of consciousness (high or low blood sugar, electrolyte imbalances, infections, etc.).

Design outcomes

Primary

MeasureTime frame
Coma recovery scale-revised Score;

Secondary

MeasureTime frame
Glasgow Coma Scale Score;Brainstem auditory evoked potential;Upper somatosensory evoked potential;

Countries

China

Contacts

Public ContactChen Hanbo

Guangdong Sanjiu Brain Hospital

117746949@qq.com+86 20 6232 3939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 2, 2026