NCT03207048

Brief Summary

This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

June 30, 2017

Last Update Submit

April 23, 2020

Conditions

Cognitive ImpairmentRelapseBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in the MATRICS Consensus Cognitive Battery

    Changes in neurocognitive and social function (measured by the The MATRICS Consensus Cognitive Battery) after 2 session of rTMS treatments (20 times)

    one weeks after the completion of the rTMS treatment)

Secondary Outcomes (1)

  • relapses of depressive and/or hypo/mania episode

    12 months

Study Arms (2)

Active rTMS

EXPERIMENTAL

10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 15 mins each time, 5 times per week for up to 6 weeks (interrupt for 1-2 weeks after 10 times).

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation

Device: Sham repetitive transcranial magnetic stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 3-second trains with a 15-second inter-train interval, for 50 trains per session

Active rTMS
Sham repetitive transcranial magnetic stimulationDEVICE

Sham Transcranial Magnetic Stimulation

Sham rTMS

Eligibility Criteria

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

You may qualify if:

  • Bipolar Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  • Age 18-60 years
  • Rating on 24-items Hamilton Depression Rating Scale (HAMD)\<18
  • Rating on the Young Mania Rating Scale (YMRS) \< 12

You may not qualify if:

  • History of any DSM-IV Axis I diagnosis other than BD Type I or II
  • Implanted medication pump or cardiac pacemaker;
  • Have had prior brain surgery
  • Any metal in the head (except in mouth)
  • Any disease of increased Intracranial pressure
  • Suicide attempt
  • Pharmacotherapy
  • unstable medical conditions
  • in the process of changing and redrawing withdrawing psychoactive medications within the past 4 weeks (except for sleeping medications such as benzodiazepines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, 510370, China

Location

Related Publications (2)

  • Martin DM, McClintock SM, Forster JJ, Lo TY, Loo CK. Cognitive enhancing effects of rTMS administered to the prefrontal cortex in patients with depression: A systematic review and meta-analysis of individual task effects. Depress Anxiety. 2017 Nov;34(11):1029-1039. doi: 10.1002/da.22658. Epub 2017 May 24.

    PMID: 28543994BACKGROUND

  • Kedzior KK, Schuchinsky M, Gerkensmeier I, Loo C. Challenges in comparing the acute cognitive outcomes of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) vs. electroconvulsive therapy (ECT) in major depression: A systematic review. J Psychiatr Res. 2017 Aug;91:14-17. doi: 10.1016/j.jpsychires.2017.03.002. Epub 2017 Mar 2.

    PMID: 28288306BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionRecurrenceBipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • kangguang Lin, MD; PhD

    Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

    PRINCIPAL INVESTIGATOR

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 GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 2, 2017

Study Start

July 10, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations

CN(1)