Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-60
SponsorThe Second Hospital of Anhui Medical University
About this trial
To investigate the effect of Temporal Interference Stimulation (TIS) on associative memory (AM) in patients with depressive disorder
Eligibility criteria
This trial accepts healthy volunteersQualifiers
the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, BSS>6, PHQ-15>5.
the age ranged from 18 to 65 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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Temporal Interference Stimulation (TIS)
DeviceThe total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.
Sham temporal interference stimulation (TIS)
DeviceSham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: real stimulationActive comparator 1 intervention
Group B: sham stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
face-word assciative memory task score
In the face-cued word association test, participants viewed 12 grayscale photographs of faces on a computer screen, each shown for 4 seconds. Each photograph was paired with a distinct word, which participants read aloud when shown. Participants were instructed to memorize the word linked to each face. One minute later, participants viewed the same 12 faces in a new random order. They were then asked to recall the associated words. Each face was scored as correct or incorrect, and the total number of correct responses formed the AM score.
Time frame
baseline and immediately after the intervention2
Change in Hamilton Depression Rating Scale (HAMD) Score
The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Time frame
baseline and immediately after the intervention3
Change in the Patient Health Questionnaire-15 (PHQ-15) scale
The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.
Time frame
baseline and immediately after the interventionSecondary outcomes
1
MRI measures
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Time frame
baseline and immediately after the intervention2
Dot-probe Task
Using the Chinese Affective Face Picture System, select 20 negative emotional faces, 20 positive emotional faces, and 40 neutral emotional faces, with an equal ratio of male and female faces. Match the positive and negative faces with neutral faces respectively. Run a standardized dot-probe paradigm using E-Prime software. First, a fixation point is displayed in the center of the screen for 1000 ms, followed by a pair of face images for 1000 ms-one emotional face and one neutral face. After the images disappear, a probe will randomly appear on either the left or right side. Press "A" for the left side and "L" for the right side. Record the participants' reaction time and accuracy in response to positive-neutral, neutral-neutral, and negative-neutral image pairs to evaluate attentional bias. Shorter reaction times and higher accuracy indicate higher scores.
Time frame
baseline and immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov