Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder
1 other identifier
interventional
40
1 country
1
Brief Summary
To investigate the intervention effect of transcranial alternating current stimulation(tACS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedOctober 17, 2023
October 1, 2023
1.7 years
August 31, 2023
October 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
anxiety symptoms
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
baseline and immediately after intervention
resting-state functional connectivity
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.
baseline and immediately after intervention
Secondary Outcomes (3)
somatic symptoms
baseline and immediately after intervention
SAS(Self-rating anxiety scale)
baseline and immediately after intervention
ISI(The insomnia severity index)
baseline and immediately after intervention
Study Arms (2)
real stimulation
ACTIVE COMPARATORParticipants will receive active tACS twice daily for one week. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz.
sham stimulation
SHAM COMPARATORParticipants will receive sham tACS twice daily for one week. Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Interventions
tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Eligibility Criteria
You may qualify if:
- the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety, and HAMA\>14, PHQ-15\>5.
- the age ranged from 18 to 60 years old, and the length of education was more than 5 years.
- the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.
You may not qualify if:
- accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
- accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women. accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
- patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.
- those who could not cooperate with those who completed the relevant experiments, such as patients with depressive stupor, claustrophobia and so on.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anhui Medical University
Hefei, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of medical psychological department, Anhui Medical University
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 7, 2023
Study Start
November 1, 2022
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
October 17, 2023
Record last verified: 2023-10