Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

Last updated: July 23, 2024
Sponsor: Tianjin Anding Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bipolar Disorder

Depression (Treatment-resistant)

Depression

Treatment

deep Transcranial Magnetic Stimulation (dTMS) -active

deep Transcranial Magnetic Stimulation (dTMS) -sham

Clinical Study ID

NCT06524505
dTMS-TJAH
  • Ages 18-65
  • All Genders

Study Summary

The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. we hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Confirmed diagnosis of bipolar depression;

  • Met standardized criteria for failure to achieve remission from pharmacologicaltreatment in the current illness episode;

  • Pharmacological treatment maintained unchanged for the four weeks preceding rTMSapplication;

  • Able to read, verbalize understanding and voluntarily sign the informed consent formprior to performance of any study-specific procedures or assessments

Exclusion

Exclusion Criteria:

  • Previous treatment with rTMS;

  • Ferromagnetic material close to the head;

  • Cardiac pacemaker and/or implanted electronic device;

  • The presence of neurological disorders (uncontrolled epilepsy, previous significanthead injuries, brain surgery);

  • Pregnancy or lactation;

  • Significant medical and/or psychiatric comorbidities;

  • Substance abuse in the last three months (not including caffeine or nicotine);

  • Acute psychosis;

  • Acute suicidality;

  • Patient refuses to sign consent for participation in the study

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: deep Transcranial Magnetic Stimulation (dTMS) -active
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
November 30, 2024

Study Description

This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.

Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.

Connect with a study center

  • Tianjin Anding Hospital

    Tianjin,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.