Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-01 @ 11:16 PM
Study NCT ID:
NCT07191392
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'face-word assciative memory task score', 'timeFrame': 'baseline and immediately after the intervention', 'description': '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.'}, {'measure': 'Change in Hamilton Depression Rating Scale (HAMD) Score', 'timeFrame': 'baseline and immediately after the intervention', 'description': '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.'}, {'measure': 'Change in the Patient Health Questionnaire-15 (PHQ-15) scale', 'timeFrame': 'baseline and immediately after the intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'MRI measures', 'timeFrame': 'baseline and immediately after the intervention', 'description': 'the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.'}, {'measure': 'Dot-probe Task', 'timeFrame': 'baseline and immediately after the intervention', 'description': '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.\n\nFirst, 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder', 'Temporal Interference Stimulation']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of Temporal Interference Stimulation (TIS) on associative memory (AM) in patients with depressive disorder', 'detailedDescription': 'Depression group: thirty patients with depressive disorder diagnosed by DSM-5 were recruited from the Second Affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving TIS treatment. After meeting the inclusion criteria and obtaining informed consent. Each patient received either 30-minute or sham TIS.\n\nBefore and after the treatments, the patients had received a battery measure of neuropsychological tests, and MRI scan in multimodalities. Neuropsychological assessment included HAMD, ANSAQ, HAMA, PHQ15, BSSI, PSQI, ISI, RRS, Barratt,Buss\\&Perry and PVAQ. Multimodal MRI includes 3D-T1, rs-fMRI, and DTI.\n\nHealthy controls: thirty healthy participants, who met the same exclusion criteria as the depressed patients but without a diagnosis of depression, were matched to the patients in terms of age, sex, and years of schooling.\n\nThe incidental memory task with emotional pictures were applied to evaluate the associative memory (AM) of thirty depressed patients at pre- and post-TIS compared to thirty healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* the age ranged from 18 to 65 years old, and the length of education was more than 5 years.\n* the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.\n\nExclusion Criteria:\n\n* accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.\n* accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.\n* accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective'}, 'identificationModule': {'nctId': 'NCT07191392', 'briefTitle': 'Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Anhui Medical University'}, 'officialTitle': 'Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder', 'orgStudyIdInfo': {'id': 'AHMU-TIS-MDD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'real stimulation', 'description': 'Participants will receive active TIS 10 to 14 times.', 'interventionNames': ['Device: Temporal Interference Stimulation (TIS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham stimulation', 'description': 'Participants will receive sham TIS 10 to 14 times.', 'interventionNames': ['Device: Sham temporal interference stimulation (TIS)']}], 'interventions': [{'name': 'Temporal Interference Stimulation (TIS)', 'type': 'DEVICE', 'description': 'The 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.', 'armGroupLabels': ['real stimulation']}, {'name': 'Sham temporal interference stimulation (TIS)', 'type': 'DEVICE', 'description': 'Sham 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', 'armGroupLabels': ['sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanghua Tian, PhD', 'role': 'CONTACT', 'email': 'ayfytyh@126.com', 'phone': '0551 6599 7278'}], 'facility': 'Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Yanghua Tian, PhD', 'role': 'CONTACT', 'email': 'zylykd@163.com', 'phone': '0551 6599 7278'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President of Anhui Medical University', 'investigatorFullName': 'Yanghua Tian', 'investigatorAffiliation': 'The Second Hospital of Anhui Medical University'}}}}