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Rehabilitation using tDCS for patients with consciousness disorders

Verification of Effective Stimulation Sites for transcranial Direct Current Stimulation in Rehabilitation of Severe Consciousness Disorders - Coma-tDCS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042240088
Enrollment
36
Registered
2024-09-24
Start date
2025-01-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

prolonged consciousness disorder Neurorehabilitation, transcranial direct current, consciousness disturbance

Interventions

Patients will be randomly assigned to Treatment Group A or Treatment Group B immediately after enrollment, and stimulation with tDCS (Compact DC Stimulator GD-800, OG Wellness Corporation) will be per
tDCS

Sponsors

Takahashi Chiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with consciousness disorders persisting for more than 3 months due to traumatic brain injury, stroke, inflammatory brain diseases, hypoxic or metabolic encephalopathy. 2.Patients classified as MCS or UWS in terms of disease type. 3.Age at consent acquisition: 20 to 90 years old (However, individuals who were capable of making independent decisions in daily life and expressing their intentions before the onset of illness). 4.Prior to participation in this study, written consent is obtained either from the relatives up to the second degree of kinship, based on their voluntary decision, or from the patient's family if the patient is unable to make judgments, following sufficient informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with poorly controlled epilepsy ( occurring within the past 1 years) 2. Patients with cranial bone defects due to decompression surgery 3. Patients with extensive titanium mesh or artificial bone insertion directly beneath the planned stimulation site following cranioplasty 4. Psychiatric disorders 5. Patients with inserted extradural electrodes, DBS electrodes, ITB pumps, or spinal cord stimulation devices 6. Patients with troubles such as dermatitis and skin cancer at the site of planned electrode attachment 7. Patients with pacemakers or ICDs 8. Pregnant women 9. Complication of malignant tumor 10. Tendency of hemorrhage 11. People with acute illnesses such as infectious diseases, febrile diseases, tuberculousis 12. Abnormal blood pressure: Cases deviating from the average blood pressure of 60 mmHg to 150 mmHg 13. Individuals diagnosed with osteoporosis 14. Individuals have recieved botulinum therapy within 3 month 15. Cases deemed inappropriate as subjects for the study by the principal investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
Change in CRS-R Score (Coma Recovery Score-Revised)

Secondary

MeasureTime frame
*Comparison of NPS (Normalized activity topography) and NPV (Normalized power variance) between pre-stimulation and post-stimulation: *AI (Asymmetry Index) of theta, alpha, and beta frequency bands in F3F4, O1O2, CzOz, and FpzOz brain regions. *Triple correlation values of brainwaves (F3F4Fpz, C1C2Oz). *Frequency evaluation of alpha waves in the occipital lobe during the course of treatment. Occurrence of adverse events.

Contacts

Public ContactChiaki Takahashi

Kanazawa Medical University Hospital

chiakit@kanazawa-med.ac.jp+81-762862211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026