NCT06109480

Brief Summary

To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) assisted Electroconvulsive Therapy (ECT) for depressive disorder.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

October 21, 2023

Last Update Submit

November 15, 2023

Conditions

Transcranial Direct Current StimulationElectroconvulsive TherapyDepressive Disorder

Keywords

Transcranial Direct Current StimulationElectroconvulsive therapyDepressive Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)

  • Change in Associative Memory

    The associative memory was estimated using a face-cued word association test. In the face-cued word association test, participants studied 12 human face photographs presented individually in grayscale on a computer screen for 4 s per face. Each photograph displayed a unique common word that the participants read aloud as each face-word pair was shown. The participants were instructed to memorize the word associated with each face. After the face-word pairs were presented, participants were shown the same 12 faces, individually and in a different and randomized order. They were asked to recall the words that were presented with each face. Each face was scored as correct or incorrect.These processes are carried out 2 times in total.The average number of successful answers was defined as the associative memory score.

    baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)

Secondary Outcomes (3)

  • Change in Hamilton Anxiety Scale (HAMA) Score

    baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)

  • Change in the Patient Health Questionnaire-15 (PHQ-15) scale

    baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)

  • Change in Working Memory

    baseline, the third day(immediately after the ECT intervention),the eighth day(immediately after the tDCS intervention)

Study Arms (3)

ECT combined with real stimulation tDCS group

ACTIVE COMPARATOR

Bifrontal short-pulse ECT was performed once a day for 3 consecutive days. Then,tDCS stimulates the dorsomedial prefrontal cortex. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. 2-mA (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes Twice a day over 10 consecutive sessions.

Device: High definition transcranial direct current stimulationDevice: electroconvulsive therapy device

ECT combined with sham stimulation tDCS group

SHAM COMPARATOR

Bifrontal short-pulse ECT was performed once a day for 3 consecutive days. Then,Sham HD-tDCS 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.

Device: Sham High definition transcranial direct current stimulationDevice: electroconvulsive therapy device

ECT full course group

OTHER

The ECT full corse group was used as a standard control.Bifrontal short-pulse ECT was performed once a day for 3 consecutive days,and then once every other day, for a total of 6 times.

Device: electroconvulsive therapy device

Interventions

High definition transcranial direct current stimulationDEVICE

tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.

ECT combined with real stimulation tDCS group
Sham High definition transcranial direct current stimulationDEVICE

Sham HD-tDCS 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.

ECT combined with sham stimulation tDCS group
electroconvulsive therapy deviceDEVICE

ECT induces brief generalized epileptic seizures by electric current to stimulate the forehead under general anesthesia

ECT combined with real stimulation tDCS groupECT combined with sham stimulation tDCS groupECT full course group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD\>17.
  • Meets the ECT treatment indication
  • 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.
  • with a history of ECT treatment within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Yanghua Tian, PhD

    Anhui Medical University

    STUDY CHAIR

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62923704wangkai1964@126.com

Yanghua Tian, PhD

CONTACT

+8613955188448ayfytyh@126.com

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

October 21, 2023

First Posted

October 31, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

CN(1)