Rehabilitation using tDCS for patients with consciousness disorders

JRCT ID: jRCTs042240088

Registered date:24/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prolonged consciousness disorder
• Date of first enrollment: 24/09/2024
• Target sample size: 36
• Study type: Interventional

Intervention(s)

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 performed during occupational therapy (OT) or physical therapy (PT).
The tDCS will be applied 10 times on weekdays only, for 20 minutes each time, with a stimulus intensity of 2 mA. In Treatment Group A, the anode is attached to the orbitofrontal cortex (Fpz) and the cathode to the side where muscle tension is to be relieved. In Treatment Group B, the anode is attached to the left dorsolateral prefrontal cortex (F3) and the cathode to the right frontal cortex (Fp2) for stimulation.

Outcome(s)

• Primary Outcome: Change in CRS-R Score (Coma Recovery Score-Revised)

Secondary Outcome

*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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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 years or older and under 80 years.
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.

Exclude 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

Related Information

• Primary Sponsor: Takahashi Chiaki
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Kanazawa Medical University