The Usage of tDCS in Patients With Disorders of Consciousness
| Registry | NCT03475537 |
|---|---|
| Status | Withdrawn - short of euqitments |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Sponsor | First Affiliated Hospital of Zhejiang University (Other) |
| Conditions | Consciousness Disorder, Transcranial Direct Current Stimulation |
| Interventions | transcranial direct current stimulation (Device) |
| Dates | start 2018-04-15 (estimated), primary completion 2019-07-15 (estimated), completion 2020-01-15 (estimated), first posted 2018-03-23, last updated 2019-10-23 |
| Locations | 1 site in China |
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Neurostimulation techniques such as deep brain stimulation (DBS) and spinal cord stimulation (SCS) have been used to treat DOC. Although these techniques have been shown to increase patient response, there are still some limitations. For example, DBS requires craniotomy and may increase the risk of intracranial hemorrhage and infection. In addition, the complexity and cost of these technologies also limit their potential applications.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| the treatment of transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulation | Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7×5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. |
Sex: Male, ages: 18 Years to 80 Years
Inclusion Criteria: Patients with DOC: VS and MCS (the cause of unification is: traumatic brain injury, the course of more than 1 month, not more than 1 year ; age 18-65; Past history without a mental disorder; No previous alcohol or substance abuse; No epilepsy or frequent spontaneous movement; No benzodiazepines; No moderate or severe hydrocephalus, All patients were right handed. Exclusion Criteria: Exclusion of organic heart disease, such as sinus bradycardia, arrhythmia; exclusion of patients with intracranial metal devices, pacemakers or any other device.
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University | Hangzhou, Zhejiang | China |