Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders

NCT06896279 | Recruiting DMC

• 1 other identifier: HY-TI2024-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.

Conditions

Disorder of Consciousness; Temporal Interference Stimulation

Keywords

Disorder of Consciousness; Randomized clinical trail; Temporal Interference Stimulation

Outcome Measures

Primary Outcomes (1)

• Effective rate of awakening

  The CRS-R is employed, with a minimum of 5 CRS-R assessments conducted at each follow-up time point, accompanied by simultaneous video recording. And the highest value is scored as a state of consciousness. The clinical assessment of participants' consciousness is deemed significantly improved when it fulfills the following criteria: a) MCS- recover to consciousness level of MCS+ or higher; b) Vegetative state(VS) recover to consciousness level of MCS- or higher; c) MCS status (MCS- or MCS+) recover to emergence from MCS (restoration of functional communication).

  Stimulation for 1 month

Secondary Outcomes (7)

• The difference of CRS-R scale relative to baseline between TI group and sham group

  Stimulation begin for 14 days, 1 month and 3 months

• The difference of Simplified Evaluation of CONsciousness Disorders (SECONDs) scale relative to baseline between TI group and sham group

  Stimulation begin for 14 days, 1 month and 3 months

• The difference of modified Ashworth scale relative to baseline between TI group and sham group

  Stimulation begin for 14 days, 1 month and 3 months

• The difference of Nociception Coma Scale-Revised (NCS-R) scale relative to baseline between TI group and sham group

  Stimulation begin for 14 days, 1 month and 3 months

• The difference of effective rate of awakening between TI group and sham group by CRS-R scale

  Stimulation begin for 1 month and 3 months

Study Arms (2)

TI stimulation group

EXPERIMENTAL

The two high-frequency electric fields of the TI device are set at different frequencies, thereby resulting in the generation of a low-frequency electric field that is capable of triggering brain physiological responses. The duration is 10 minutes.

Procedure: TI Stimulation

Sham TI stimulation group

SHAM COMPARATOR

The two high-frequency electric fields of the TI device are set to be completely of the same frequency (2000Hz), thus no low-frequency electric field is produced and no cerebral physiological responses are elicited. The duration lasts for 10 minutes.

Procedure: Sham Stimulation

Interventions

TI Stimulation PROCEDURE

Participants will accept the TI stimulus for one month

TI stimulation group

Sham Stimulation PROCEDURE

Participants will accept the sham TI stimulus for one month

Sham TI stimulation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender;
• Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more;
• Patients with normal body temperature, stable vital signs, spontaneous breathing, tracheotomy without the use of a metal cannula and with a small amount of sputum, and who are eligible for magnetic resonance imaging (MRI) examination;
• Written informed consent obtained from the patient's family members in advance.

You may not qualify if:

• Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney;
• Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals;
• Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future;
• Pregnant women;
• Those who have participated in other drug or device clinical trials;
• Patients with poorly controlled epilepsy in the recent period;
• Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site;
• Those currently taking medications prone to inducing epilepsy, such as quinolone drugs;
• Those with intracranial infections, intracranial tumors, or metallic objects within the cranium;
• Those allergic to electrode gel or adhesives;
• Those with implanted electronic devices within the body;
• Those with severe cardiac disorders and those equipped with cardiac pacemakers.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai First Rehabilitation Hospital: collaborator

Study Sites (2)

Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (6)

• Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.

  PMID: 37857775 RESULT

• Thibaut A, Schiff N, Giacino J, Laureys S, Gosseries O. Therapeutic interventions in patients with prolonged disorders of consciousness. Lancet Neurol. 2019 Jun;18(6):600-614. doi: 10.1016/S1474-4422(19)30031-6. Epub 2019 Apr 16.

  PMID: 31003899 RESULT

• Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. Practice guideline update recommendations summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research. Neurology. 2018 Sep 4;91(10):450-460. doi: 10.1212/WNL.0000000000005926. Epub 2018 Aug 8.

  PMID: 30089618 RESULT

• Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.

  PMID: 28575667 RESULT

• Tasserie J, Uhrig L, Sitt JD, Manasova D, Dupont M, Dehaene S, Jarraya B. Deep brain stimulation of the thalamus restores signatures of consciousness in a nonhuman primate model. Sci Adv. 2022 Mar 18;8(11):eabl5547. doi: 10.1126/sciadv.abl5547. Epub 2022 Mar 18.

  PMID: 35302854 RESULT

• Schiff ND. Recovery of consciousness after brain injury: a mesocircuit hypothesis. Trends Neurosci. 2010 Jan;33(1):1-9. doi: 10.1016/j.tins.2009.11.002. Epub 2009 Dec 1.

  PMID: 19954851 RESULT

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xuehai Wu, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehai Wu, Ph.D.

CONTACT

+86 13764880571; Wuxuehai2013@163.com

Wentao Huang, M.M.

CONTACT

+86 19370557372; hhuangwt7777@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is being conducted as a double-blind trial, wherein the surgeons, assessors and participants' family members are kept unaware of the assigned research groups. However, it is necessary to inform the physicians responsible for adjustment of stimulation parameters about the allocation of participants. Follow-up assessments of participants after stimulation will be conducted by an independent assessor using standardized evaluation criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Shanghai Neurosurgical Emergency Center

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 26, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): May 17, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)