search
Back to results

A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

Primary Purpose

Cognitive Impairment, Relapse, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham repetitive transcranial magnetic stimulation
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

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).

Sham repetitive transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

relapses of depressive and/or hypo/mania episode
The number of patients who have depression and/or hyop/mania episodes over period of 12 months.

Full Information

First Posted
June 30, 2017
Last Updated
April 23, 2020
Sponsor
Guangzhou Psychiatric Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03207048
Brief Title
A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Cognitive Function and Prevent Relapses in Bipolar Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.
Detailed Description
Cognitive deficits are core features of bipolar disorder. Preliminary evidence shows that repetitive transcranial magnetic stimulation (rTMS) might have positive effects in enhancing cognition and improving clinical symptoms in patients with depression. This study will investigate the effect of rTMS on cognition and long-term outcomes (12 month) of bipolar patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Relapse, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham repetitive transcranial magnetic stimulation
Intervention Description
Sham Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
Changes in the MATRICS Consensus Cognitive Battery
Description
Changes in neurocognitive and social function (measured by the The MATRICS Consensus Cognitive Battery) after 2 session of rTMS treatments (20 times)
Time Frame
one weeks after the completion of the rTMS treatment)
Secondary Outcome Measure Information:
Title
relapses of depressive and/or hypo/mania episode
Description
The number of patients who have depression and/or hyop/mania episodes over period of 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kangguang Lin, MD; PhD
Organizational Affiliation
Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain hospital(Guangzhou Huiai Hospital)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28543994
Citation
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.
Results Reference
background
PubMed Identifier
28288306
Citation
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.
Results Reference
background

Learn more about this trial

A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

We'll reach out to this number within 24 hrs