A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

Guangzhou Psychiatric Hospital

Status: Completed

Conditions: Cognitive Impairment; Bipolar Disorder; Relapse

Treatments: Device: Sham repetitive transcranial magnetic stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03207048

Guangzhou Psychiatric Hospital

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

42 participants in 2 patient groups

Active rTMS

Experimental group

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).

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

Sham Comparator group

Description:

Sham repetitive transcranial magnetic stimulation

Treatment:

Device: Sham repetitive transcranial magnetic stimulation