Disorder of ConsciousnessNCT06896279
Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders
A study testing TI Stimulation in people with Disorder of Consciousness and Temporal Interference Stimulation, run by Huashan Hospital at 2 sites in China.
Trial summary
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disorder of Consciousness, Temporal Interference Stimulation
- What is being tested?
- TI Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 21 Apr 2025to 17 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University
Shanghai, Shanghai Municipality, 200000
Anjing Zhang, Ph.D., +86 18930133551, sunnylovely_aj@163.com
- Recruiting
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Xuehai Wu, Ph.D., +8613764880571, Wuxuehai2013@163.com
About this study
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
Read the detailed description
Based on the central loop hypothesis, deep brain stimulation (DBS) represents a commonly utilized neuro-modulation stimulation technology for disorders of consciousness (DOC). It was initially employed in Europe in 1968 for treating DOC. Some patients can regain functional communication capabilities and even resume family life. Nevertheless, as a neurosurgical intervention, DBS implantation entails significant surgical risks and potential complications (such as cerebral edema in the surgical area, secondary cerebral hemorrhage, secondary epilepsy, postoperative brain abscess, pulse generator shutdown or circuit malfunction, displacement of stimulation electrodes or extension leads, rejection reactions), and incurs substantial costs, imposing a heavy burden on patients' families and the national medical insurance fund. Traditional non-invasive brain stimulation methods, such as transcranial alternating or direct current stimulation, although not requiring surgery, have limited focusing capacity and the ability to stimulate deep brain structures. Hence, researchers have been in pursuit of approaches to precisely and effectively stimulate deep brain regions without the need for surgery.
In 2017, the concept of temporal interference (TI) stimulation, a novel non-invasive method for regulating deep brain regions was put forward . The fundamental principle of TI stimulation is that two interfering high-frequency signals will generate a low-frequency amplitude-modulated electric field, which can drive the discharge of deep brain neurons. Furthermore, by fixing the sum of the input currents of two pairs of electrodes and altering the current input ratio of the two pairs of electrodes, the movement of the mouse's forepaws, whiskers, and ears without modifying the spatial position of the electrodes could be achieved. Therefore, TI stimulation enables the flexible movement of the stimulation target area within the brain without electrode displacement. Despite the fact that research on TI technology is still in its nascent stage, this method has demonstrated substantial potential in neuroscience and clinical therapy.
Consequently, the objective of this multicenter randomized controlled trial is to assess the therapeutic effect of temporal interference stimulation in awakening patients with severe disorders of consciousness and verify its safety. Simultaneously, it aims to clarify issues such as the clinical application indications, operational parameters of TI. This will facilitate a deeper comprehension of the effectiveness, clinical application indications, operational parameters, and treatment plans of this emerging neuro-modulation technology as a means of awakening treatment, and promote the advancement of diagnosis and treatment technologies for patients with severe disorders of consciousness.
- Being tested
- TI Stimulation, Sham Stimulation
- Keywords
- Disorder of Consciousness, Randomized clinical trail, Temporal Interference Stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI StimulationProcedure or surgery
Participants will accept the TI stimulus for one month
Sham StimulationProcedure or surgery
Participants will accept the sham TI stimulus for one month
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Stimulation for 1 month
Secondary outcomes (7)
The difference of CRS-R scale relative to baseline between TI group and sham group
The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability.
Measured: 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
The SECONDs is a fast tool to assess consciousness in brain-injured patients. The minimum score is 0 and the maximum is 8, higher scores mean a better outcome.
Measured: 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
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The minimum grade is 0 and the maximum is 4, higher scores mean a worse outcome.
Measured: 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
The NCS-R was developed to help assess pain in patients with disorders of consciousness (DOC). Several studies have shown its sensitivity in assessing response to acute noxious stimuli. The minimum score is 0 and the maximum is 12, higher scores mean a better outcome.
Measured: 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
The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability.
Measured: Stimulation begin for 1 month and 3 months
The difference of effective rate of awakening between TI group and sham group by Simplified Evaluation of CONsciousness Disorders (SECONDs) scale
The SECONDs is a fast tool to assess consciousness in brain-injured patients. The minimum score is 0 and the maximum is 8, higher scores mean a better outcome.
Measured: Stimulation begin for 1 month and 3 months
The difference of recovery trajectories of consciousness level between TI group and Sham group
Measured: Stimulation for 3-month-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start21 Apr 2025
- Primary completion16 May 2026 (estimated)
- Study completion17 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Rehabilitation Hospital
- Responsible party
- Principal investigator, Xuehai Wu, Huashan Hospital
- Investigators
- Xuehai Wu, Ph.D., Principal investigator, Department of Neurosurgery, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896279
- Sponsor's protocol ID
- HY-TI2024-01
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37857775Thibaut 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.
PubMed 31003899Giacino 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.
PubMed 30089618Grossman 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.
PubMed 28575667Tasserie 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.
PubMed 35302854Schiff 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.
PubMed 19954851
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders
- ClinicalTrials.gov ID
- NCT06896279
- Acronym / sponsor ID
- HY-TI2024-01
- Keywords
- Disorder of Consciousness, Randomized clinical trail, Temporal Interference Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai First Rehabilitation Hospital
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 16 May 2026 (estimated)
- Study completion
- 17 May 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
Detailed description
Based on the central loop hypothesis, deep brain stimulation (DBS) represents a commonly utilized neuro-modulation stimulation technology for disorders of consciousness (DOC). It was initially employed in Europe in 1968 for treating DOC. Some patients can regain functional communication capabilities and even resume family life. Nevertheless, as a neurosurgical intervention, DBS implantation entails significant surgical risks and potential complications (such as cerebral edema in the surgical area, secondary cerebral hemorrhage, secondary epilepsy, postoperative brain abscess, pulse generator shutdown or circuit malfunction, displacement of stimulation electrodes or extension leads, rejection reactions), and incurs substantial costs, imposing a heavy burden on patients' families and the national medical insurance fund. Traditional non-invasive brain stimulation methods, such as transcranial alternating or direct current stimulation, although not requiring surgery, have limited focusing capacity and the ability to stimulate deep brain structures. Hence, researchers have been in pursuit of approaches to precisely and effectively stimulate deep brain regions without the need for surgery.
In 2017, the concept of temporal interference (TI) stimulation, a novel non-invasive method for regulating deep brain regions was put forward . The fundamental principle of TI stimulation is that two interfering high-frequency signals will generate a low-frequency amplitude-modulated electric field, which can drive the discharge of deep brain neurons. Furthermore, by fixing the sum of the input currents of two pairs of electrodes and altering the current input ratio of the two pairs of electrodes, the movement of the mouse's forepaws, whiskers, and ears without modifying the spatial position of the electrodes could be achieved. Therefore, TI stimulation enables the flexible movement of the stimulation target area within the brain without electrode displacement. Despite the fact that research on TI technology is still in its nascent stage, this method has demonstrated substantial potential in neuroscience and clinical therapy.
Consequently, the objective of this multicenter randomized controlled trial is to assess the therapeutic effect of temporal interference stimulation in awakening patients with severe disorders of consciousness and verify its safety. Simultaneously, it aims to clarify issues such as the clinical application indications, operational parameters of TI. This will facilitate a deeper comprehension of the effectiveness, clinical application indications, operational parameters, and treatment plans of this emerging neuro-modulation technology as a means of awakening treatment, and promote the advancement of diagnosis and treatment technologies for patients with severe disorders of consciousness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TI stimulation group | Experimental | Procedure: TI StimulationThe 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. |
| Sham TI stimulation group | Sham comparator | Procedure: Sham StimulationThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TI StimulationParticipants will accept the TI stimulus for one month | Procedure or surgery | TI stimulation group |
| Sham StimulationParticipants will accept the sham TI stimulus for one month | Procedure or surgery | Sham TI stimulation group |
Primary outcome
Effective rate of awakening
Time frame: Stimulation for 1 month
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).
7 secondary outcomes
The difference of CRS-R scale relative to baseline between TI group and sham group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Stimulation begin for 1 month and 3 months
The difference of effective rate of awakening between TI group and sham group by Simplified Evaluation of CONsciousness Disorders (SECONDs) scale
Time frame: Stimulation begin for 1 month and 3 months
The difference of recovery trajectories of consciousness level between TI group and Sham group
Time frame: Stimulation for 3-month-stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 37857775Violante 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.
- Results publication: PubMed 31003899Thibaut 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.
- Results publication: PubMed 30089618Giacino 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.
- Results publication: PubMed 28575667Grossman 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.
- Results publication: PubMed 35302854Tasserie 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.
- Results publication: PubMed 19954851Schiff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuehai Wu, Ph.D. principal investigator
Department of Neurosurgery, Huashan Hospital, Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI Stimulation in people with Disorder of Consciousness and Temporal Interference Stimulation, run by Huashan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuehai Wu, Ph.D. (+86 13764880571, Wuxuehai2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate of awakening (time frame: Stimulation for 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06896279, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.