NCT03991572

Brief Summary

Study of individualized accurate targeting rTMS intervention on motivational anhedonia of treatment resistant depression and brain network mechanism

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

4 years

First QC Date

April 22, 2019

Last Update Submit

June 18, 2019

Conditions

Treatment Resistant DepressionTranscranial Magnetic StimulationFunctional Magnetic Resonance ImagingEvent-Related Potentials

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Hamilton Depression Scale

    The participants' depression symptom assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale change from baseline after the treatment.

    baseline;15 day post-treatment

  • Change from baseline in Motivation and Pleasure Scale

    The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.

    baseline;15 day post-treatment

Secondary Outcomes (3)

  • The change from baseline in behavioral results of Monetary Incentive Delay task

    baseline; 15 day post-treatment change from baseline after the treatment.

  • The change from baseline in event-related brain potentials during the monetary incentive delay task

    baseline; 15 day post-treatment

  • The change from baseline in neuroimaging results of functional magnetic resonance imaging scan in multimodalities

    baseline; 15 day post-treatment

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

The Real Stimulation of rTMS lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold (RMT) . Behavior and MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

Device: repeated transcranial magnetic stimulation with real coil

Sham Stimulation

SHAM COMPARATOR

The procedure of Sham Stimulation protocol was performed by a placebo coil,lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

Device: repeated transcranial magnetic stimulation with sham coil

Interventions

repeated transcranial magnetic stimulation with real coilDEVICE

repeated transcranial magnetic stimulation with real coil is a noninvasive technique to activate and modify the activity of the neurons

Real Stimulation
repeated transcranial magnetic stimulation with sham coilDEVICE

repeated transcranial magnetic stimulation with sham coil is a placebo

Sham Stimulation

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • History of significant head trauma or neurological disorders.
  • Alcohol or drug abuse.
  • Focal brain lesions.
  • History of seizure.
  • First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
  • Significant unstable medical condition.
  • Recent aggression or other forms of behavioral dyscontrol.
  • Left-handedness.
  • Pregnancy.
  • Current alcohol or drug abuse
  • Inability to provide informed consent.
  • Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

Related Publications (1)

  • Wang X, He K, Chen T, Shi B, Yang J, Geng W, Zhang L, Zhu C, Ji G, Tian Y, Bai T, Dong Y, Luo Y, Wang K, Yu F. Therapeutic efficacy of connectivity-directed transcranial magnetic stimulation on anticipatory anhedonia. Depress Anxiety. 2021 Sep;38(9):972-984. doi: 10.1002/da.23188. Epub 2021 Jun 22.

    PMID: 34157193DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Kai Wang, MD

    Anhui Medical University

    STUDY CHAIR

  • Fengqiong Yu, MD

    Anhui Medical University

    STUDY DIRECTOR

Central Study Contacts

Fengqiong Yu, MD

CONTACT

0086055115955155423yufengqin1@163.com

Tingting Chen, Master

CONTACT

0086055115255564633915402624@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof.

Study Record Dates

First Submitted

April 22, 2019

First Posted

June 19, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

CN(1)