A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

NCT ID: NCT03207048

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cognitive Impairment Relapse Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active rTMS

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).

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Sham rTMS

Sham repetitive transcranial magnetic stimulation

Group Type SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Sham Transcranial Magnetic Stimulation

Interventions

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Repetitive Transcranial Magnetic Stimulation

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

Sham repetitive transcranial magnetic stimulation

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kangguang Lin

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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kangguang Lin, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

Locations

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Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 28543994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28288306 (View on PubMed)

Other Identifiers

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Guangzhou Psychiatric Hospital

Identifier Type: -

Identifier Source: org_study_id

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