Generalized Anxiety Disorder (GAD)NCT06775145
Therapeutic Effect of Neuromodulation on Anxiety Disorders by High-Definition Transcranial Electrical Stimulation
A study testing HD-R_cDC+cTBS & HD-L_aDC+iTBS in people with Generalized Anxiety Disorder (GAD), run by National Taiwan University Hospital.
Trial summary
High-definition transcranial electrical stimulation (HD-tES) is a non-invasive brain neuromodulation technique that applies a small electrical current to the scalp to alter neural excitability and stimulate localized brain activation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- HD-R_cDC+cTBS & HD-L_aDC+iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2025to 31 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Diagnosed with Generalized Anxiety Disorder (GAD) by a psychiatrist according to DSM-5 criteria.
- Hamilton Anxiety Rating Scale (HAM-A) score ≥ 14.
- Hamilton Depression Rating Scale (HAM-D; 17-item version) score ≤ 17.
- Has been consistently receiving psychological counseling and/or medication with stable types and dosages for at least 6 weeks prior to enrollment; or is deemed unsuitable for medication and/or psychological counseling; or refuses medication and/or psychological counseling.
Who cannot join
- Received rTMS or any other form of non-invasive brain stimulation techniques within 2 weeks prior to the study and during the study period.
- Presence of severe neurological disorders (e.g., stroke, brain tumor, epilepsy, organic brain diseases) or psychiatric disorders (e.g., schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, other types of anxiety disorders, substance abuse).
- Severe or unstable physiological conditions that may affect the autonomic or central nervous system (e.g., acute gastrointestinal diseases, cardiovascular diseases, thyroid disorders).
- History of cardiac arrhythmia.
- Presence of implanted medical electronic devices (e.g., pacemakers).
- Presence of metallic implants in the head or neck region.
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- Open wounds on the scalp at the site of electrode contact.
- History of head surgery or significant head trauma that, based on physician evaluation, makes the individual unsuitable for inclusion.
- Individuals with significant suicide risk (HAM-D Item 3 score on suicidal risk ≥ 3).
- Presence of immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel diseases).
- Individuals with abnormal or heightened sensitivity to electrical stimulation, making them unable to tolerate it.
- Pregnancy (for female participants: must be postmenopausal or surgically sterilized. Females of childbearing potential must have a negative pregnancy test. Female participants capable of becoming pregnant and their male partners with female partners capable of becoming pregnant must agree to use effective contraception during the trial and for 4 months after the last study intervention, such as oral contraceptives, dual barrier methods, or intrauterine devices, or agree to abstain from sexual activity during this period. Non-childbearing females are defined as those who have undergone bilateral oophorectomy or are postmenopausal).
- Taking medications that lower the seizure threshold.
- Alcohol or substance abuse.
- Convexity skull defects or elevated intracranial pressure.
- Breastfeeding women.
- Other conditions deemed unsuitable for transcranial electrical stimulation based on physician evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
High-definition transcranial electrical stimulation (HD-tES) is a non-invasive brain neuromodulation technique that applies a small electrical current to the scalp to alter neural excitability and stimulate localized brain activation. Previous clinical trials have explored the use of HD-tES for treating mental health conditions such as depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder. This trial aims to investigate the efficacy and safety of HD-tES in ameliorating anxiety symptoms among patients with generalized anxiety disorder (GAD), thereby validating its potential as a treatment for anxiety disorders.
Participants will be randomly assigned to one of four HD-tES treatment groups: (1) HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. (2) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (3) HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (4) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. Regardless of the group assignment, participants will undergo treatment sessions over a 2-week period, with five sessions per week and no more than one session per day. Each session lasts approximately 20 minutes. Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- HD-R_cDC+cTBS & sham-L_aDC+iTBS, sham-R_cDC+cTBS & HD-L_aDC+iTBS, HD-R_cDC+cTBS & HD-L_aDC+iTBS, sham-R_cDC+cTBS & sham-L_aDC+iTBS
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-R_cDC+cTBS & sham-L_aDC+iTBSDevice
HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes.
sham-R_cDC+cTBS & HD-L_aDC+iTBSDevice
Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes.
HD-R_cDC+cTBS & HD-L_aDC+iTBSDevice
HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes.
sham-R_cDC+cTBS & sham-L_aDC+iTBSDevice
Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HD-R_cDC+cTBS & sham-L_aDC+iTBS | Experimental | Not described Receives: Device: HD-R_cDC+cTBS & sham-L_aDC+iTBS |
| sham-R_cDC+cTBS & HD-L_aDC+iTBS | Experimental | Not described Receives: Device: sham-R_cDC+cTBS & HD-L_aDC+iTBS |
| HD-R_cDC+cTBS & HD-L_aDC+iTBS | Experimental | Not described Receives: Device: HD-R_cDC+cTBS & HD-L_aDC+iTBS |
| sham-R_cDC+cTBS & sham-L_aDC+iTBS | Sham comparator | Not described Receives: Device: sham-R_cDC+cTBS & sham-L_aDC+iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HAM-A) and after intervention
Measured: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Change in state and trait anxiety as assessed by State-Trait Anxiety Inventory (STAI) after intervention
Measured: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Secondary outcomes (5)
Change in severity of depressive symptoms as assessed by Hamilton Depression Scale (HAM-D) after intervention
Measured: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Change in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) after intervention
Measured: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Self-rated anxiety level as assessed by Visual Analog Scale (VAS)
Measured: Within 3 minute after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Heart Rate Variability (HRV) as assessed by NeXus-10MK Ⅱ
Measured: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Side effects as assessed by Side Effects Questionnaire
Measured: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start3 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775145
- Sponsor's protocol ID
- 202312116DINB
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nitsche MA, Doemkes S, Karakose T, Antal A, Liebetanz D, Lang N, Tergau F, Paulus W. Shaping the effects of transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2007 Apr;97(4):3109-17. doi: 10.1152/jn.01312.2006. Epub 2007 Jan 24.
PubMed 17251360Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Williams JA, Imamura M, Fregni F. Updates on the use of non-invasive brain stimulation in physical and rehabilitation medicine. J Rehabil Med. 2009 Apr;41(5):305-11. doi: 10.2340/16501977-0356.
PubMed 19363560Reed T, Cohen Kadosh R. Transcranial electrical stimulation (tES) mechanisms and its effects on cortical excitability and connectivity. J Inherit Metab Dis. 2018 Jul 13;41(6):1123-30. doi: 10.1007/s10545-018-0181-4. Online ahead of print.
PubMed 30006770Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PubMed 17452283Polania R, Nitsche MA, Ruff CC. Studying and modifying brain function with non-invasive brain stimulation. Nat Neurosci. 2018 Feb;21(2):174-187. doi: 10.1038/s41593-017-0054-4. Epub 2018 Jan 8.
PubMed 29311747Hummel FC, Voller B, Celnik P, Floel A, Giraux P, Gerloff C, Cohen LG. Effects of brain polarization on reaction times and pinch force in chronic stroke. BMC Neurosci. 2006 Nov 3;7:73. doi: 10.1186/1471-2202-7-73.
PubMed 17083730Guleyupoglu B, Febles N, Minhas P, Hahn C, Bikson M. Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. Front Neuroeng. 2014 Jul 11;7:28. doi: 10.3389/fneng.2014.00028. eCollection 2014.
PubMed 25071548Turski CA, Kessler-Jones A, Chow C, Hermann B, Hsu D, Jones J, Seeger SK, Chappell R, Boly M, Ikonomidou C. Extended Multiple-Field High-Definition transcranial direct current stimulation (HD-tDCS) is well tolerated and safe in healthy adults. Restor Neurol Neurosci. 2017;35(6):631-642. doi: 10.3233/RNN-170757.
PubMed 29172010Kuo HI, Bikson M, Datta A, Minhas P, Paulus W, Kuo MF, Nitsche MA. Comparing cortical plasticity induced by conventional and high-definition 4 x 1 ring tDCS: a neurophysiological study. Brain Stimul. 2013 Jul;6(4):644-8. doi: 10.1016/j.brs.2012.09.010. Epub 2012 Oct 13.
PubMed 23149292Cox J, Thakur B, Alvarado L, Shokar N, Thompson PM, Dwivedi AK. Repetitive transcranial magnetic stimulation for generalized anxiety and panic disorders: A systematic review and meta-analysis. Ann Clin Psychiatry. 2022 May;34(2):e2-e24. doi: 10.12788/acp.0050.
PubMed 35550035de Lima AL, Braga FMA, da Costa RMM, Gomes EP, Brunoni AR, Pegado R. Transcranial direct current stimulation for the treatment of generalized anxiety disorder: A randomized clinical trial. J Affect Disord. 2019 Dec 1;259:31-37. doi: 10.1016/j.jad.2019.08.020. Epub 2019 Aug 15.
PubMed 31437698Diefenbach GJ, Bragdon LB, Zertuche L, Hyatt CJ, Hallion LS, Tolin DF, Goethe JW, Assaf M. Repetitive transcranial magnetic stimulation for generalised anxiety disorder: a pilot randomised, double-blind, sham-controlled trial. Br J Psychiatry. 2016 Sep;209(3):222-8. doi: 10.1192/bjp.bp.115.168203. Epub 2016 May 19.
PubMed 27198484Dilkov D, Hawken ER, Kaludiev E, Milev R. Repetitive transcranial magnetic stimulation of the right dorsal lateral prefrontal cortex in the treatment of generalized anxiety disorder: A randomized, double-blind sham controlled clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:61-65. doi: 10.1016/j.pnpbp.2017.05.018. Epub 2017 May 19.
PubMed 28533148Huang Z, Li Y, Bianchi MT, Zhan S, Jiang F, Li N, Ding Y, Hou Y, Wang L, Ouyang Q, Wang Y. Repetitive transcranial magnetic stimulation of the right parietal cortex for comorbid generalized anxiety disorder and insomnia: A randomized, double-blind, sham-controlled pilot study. Brain Stimul. 2018 Sep-Oct;11(5):1103-1109. doi: 10.1016/j.brs.2018.05.016. Epub 2018 May 29.
PubMed 29871798
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Neuromodulation on Anxiety Disorders by High-Definition Transcranial Electrical Stimulation
- ClinicalTrials.gov ID
- NCT06775145
- Acronym / sponsor ID
- 202312116DINB
- Conditions
- Generalized Anxiety Disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jan 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.
High-definition transcranial electrical stimulation (HD-tES) is a non-invasive brain neuromodulation technique that applies a small electrical current to the scalp to alter neural excitability and stimulate localized brain activation. Previous clinical trials have explored the use of HD-tES for treating mental health conditions such as depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder. This trial aims to investigate the efficacy and safety of HD-tES in ameliorating anxiety symptoms among patients with generalized anxiety disorder (GAD), thereby validating its potential as a treatment for anxiety disorders.
Participants will be randomly assigned to one of four HD-tES treatment groups: (1) HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. (2) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (3) HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (4) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. Regardless of the group assignment, participants will undergo treatment sessions over a 2-week period, with five sessions per week and no more than one session per day. Each session lasts approximately 20 minutes. Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HD-R_cDC+cTBS & sham-L_aDC+iTBS | Experimental | Device: HD-R_cDC+cTBS & sham-L_aDC+iTBS |
| sham-R_cDC+cTBS & HD-L_aDC+iTBS | Experimental | Device: sham-R_cDC+cTBS & HD-L_aDC+iTBS |
| HD-R_cDC+cTBS & HD-L_aDC+iTBS | Experimental | Device: HD-R_cDC+cTBS & HD-L_aDC+iTBS |
| sham-R_cDC+cTBS & sham-L_aDC+iTBS | Sham comparator | Device: sham-R_cDC+cTBS & sham-L_aDC+iTBS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Diagnosed with Generalized Anxiety Disorder (GAD) by a psychiatrist according to DSM-5 criteria.
- Hamilton Anxiety Rating Scale (HAM-A) score ≥ 14.
- Hamilton Depression Rating Scale (HAM-D; 17-item version) score ≤ 17.
- Has been consistently receiving psychological counseling and/or medication with stable types and dosages for at least 6 weeks prior to enrollment; or is deemed unsuitable for medication and/or psychological counseling; or refuses medication and/or psychological counseling.
Key exclusion criteria (17 listed)
- Received rTMS or any other form of non-invasive brain stimulation techniques within 2 weeks prior to the study and during the study period.
- Presence of severe neurological disorders (e.g., stroke, brain tumor, epilepsy, organic brain diseases) or psychiatric disorders (e.g., schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, other types of anxiety disorders, substance abuse).
- Severe or unstable physiological conditions that may affect the autonomic or central nervous system (e.g., acute gastrointestinal diseases, cardiovascular diseases, thyroid disorders).
- History of cardiac arrhythmia.
- Presence of implanted medical electronic devices (e.g., pacemakers).
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 |
|---|---|---|
| HD-R_cDC+cTBS & sham-L_aDC+iTBSHD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. | Device | HD-R_cDC+cTBS & sham-L_aDC+iTBS |
| sham-R_cDC+cTBS & HD-L_aDC+iTBSSham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. | Device | sham-R_cDC+cTBS & HD-L_aDC+iTBS |
| HD-R_cDC+cTBS & HD-L_aDC+iTBSHD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. | Device | HD-R_cDC+cTBS & HD-L_aDC+iTBS |
| sham-R_cDC+cTBS & sham-L_aDC+iTBSSham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. | Device | sham-R_cDC+cTBS & sham-L_aDC+iTBS |
Primary outcome
Change in severity of anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HAM-A) and after intervention
Time frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Change in state and trait anxiety as assessed by State-Trait Anxiety Inventory (STAI) after intervention
Time frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
5 secondary outcomes
Change in severity of depressive symptoms as assessed by Hamilton Depression Scale (HAM-D) after intervention
Time frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Change in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) after intervention
Time frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Self-rated anxiety level as assessed by Visual Analog Scale (VAS)
Time frame: Within 3 minute after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Heart Rate Variability (HRV) as assessed by NeXus-10MK Ⅱ
Time frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Side effects as assessed by Side Effects Questionnaire
Time frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
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 14 Jan 2025.
- Background: PubMed 17251360Nitsche MA, Doemkes S, Karakose T, Antal A, Liebetanz D, Lang N, Tergau F, Paulus W. Shaping the effects of transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2007 Apr;97(4):3109-17. doi: 10.1152/jn.01312.2006. Epub 2007 Jan 24.
- Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
- Background: PubMed 19363560Williams JA, Imamura M, Fregni F. Updates on the use of non-invasive brain stimulation in physical and rehabilitation medicine. J Rehabil Med. 2009 Apr;41(5):305-11. doi: 10.2340/16501977-0356.
- Background: PubMed 30006770Reed T, Cohen Kadosh R. Transcranial electrical stimulation (tES) mechanisms and its effects on cortical excitability and connectivity. J Inherit Metab Dis. 2018 Jul 13;41(6):1123-30. doi: 10.1007/s10545-018-0181-4. Online ahead of print.
- Background: PubMed 17452283Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
- Background: PubMed 29311747Polania R, Nitsche MA, Ruff CC. Studying and modifying brain function with non-invasive brain stimulation. Nat Neurosci. 2018 Feb;21(2):174-187. doi: 10.1038/s41593-017-0054-4. Epub 2018 Jan 8.
- Background: PubMed 17083730Hummel FC, Voller B, Celnik P, Floel A, Giraux P, Gerloff C, Cohen LG. Effects of brain polarization on reaction times and pinch force in chronic stroke. BMC Neurosci. 2006 Nov 3;7:73. doi: 10.1186/1471-2202-7-73.
- Background: PubMed 25071548Guleyupoglu B, Febles N, Minhas P, Hahn C, Bikson M. Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. Front Neuroeng. 2014 Jul 11;7:28. doi: 10.3389/fneng.2014.00028. eCollection 2014.
- Background: PubMed 29172010Turski CA, Kessler-Jones A, Chow C, Hermann B, Hsu D, Jones J, Seeger SK, Chappell R, Boly M, Ikonomidou C. Extended Multiple-Field High-Definition transcranial direct current stimulation (HD-tDCS) is well tolerated and safe in healthy adults. Restor Neurol Neurosci. 2017;35(6):631-642. doi: 10.3233/RNN-170757.
- Background: PubMed 23149292Kuo HI, Bikson M, Datta A, Minhas P, Paulus W, Kuo MF, Nitsche MA. Comparing cortical plasticity induced by conventional and high-definition 4 x 1 ring tDCS: a neurophysiological study. Brain Stimul. 2013 Jul;6(4):644-8. doi: 10.1016/j.brs.2012.09.010. Epub 2012 Oct 13.
- Background: PubMed 35550035Cox J, Thakur B, Alvarado L, Shokar N, Thompson PM, Dwivedi AK. Repetitive transcranial magnetic stimulation for generalized anxiety and panic disorders: A systematic review and meta-analysis. Ann Clin Psychiatry. 2022 May;34(2):e2-e24. doi: 10.12788/acp.0050.
- Background: PubMed 31437698de Lima AL, Braga FMA, da Costa RMM, Gomes EP, Brunoni AR, Pegado R. Transcranial direct current stimulation for the treatment of generalized anxiety disorder: A randomized clinical trial. J Affect Disord. 2019 Dec 1;259:31-37. doi: 10.1016/j.jad.2019.08.020. Epub 2019 Aug 15.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing HD-R_cDC+cTBS & HD-L_aDC+iTBS in people with Generalized Anxiety Disorder (GAD), run by National Taiwan University Hospital.
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 5 inclusion and 17 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: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yi Jing Huang (+886 2-33668166, yijinghuang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HAM-A) and after intervention (time frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.). The study lists 2 primary outcomes in all. 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 NCT06775145, which also lists 63 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 14 Jan 2025.