The development of novel treatment using transcranial magnetic stimulation for patients with mood disorders

JRCT ID: jRCTs062180023

Registered date:18/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mood disorders (major depressive disorder and bipolar disorder) and healthy volunteers
• Date of first enrollment: 01/12/2015
• Target sample size: 70
• Countries of recruitment: Japan only,Japan
• Study type: Interventional

Intervention(s)

For depressive patients, repetitive TMS will be applied with the following parameters below.
Target location: left dorsolateral prefrontal cortex localized by a spatial navigation system
Stimulation frequency: ~10Hz
Stimulation intensity: ~120% of individual's resting motor threshold
Number of pulses: 2000-3000 pulses/day
Number of total sessions: 20-30 sessions

For healthy-control individuals, causally examine regionally interconnected brain regions by single-pulse TMS during a session (rather than after multiple sessions).

Outcome(s)

Primary Outcome

For patients with mood disorders
1) Severity assessment of mood disorders: evaluate changes after each session by PANAS, and changes after all the sessions by HRSD or BDI-II.
2) Assessment of changes in brain activity associated with the treatment effects: evaluate changes in brain activity (changes in signals of each brain region on fMRI, EEG and NIRS before and after the treatment) associated with the treatment effects, such as in severity of mood disorders (assessed by HRSD or BDI-II), rumination (assessed by RRQ or RRS) and physical sensation (assessed by recognition evaluation for physical sensation) .
For healthy controls
3) Viability assessment of manipulation of neural activity: evaluate the desired brain activity or functional connectivity patterns by brain functional imaging to check whether they can be induced or not.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

[ For patients/clients ]
1) Aged 20-80 years old
2) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM-IV-TR or DSM-V
3) Current diagnosis of major depressive episode
4) Present treatment-resistance (scores with 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after >=4 weeks of treatment with sufficient amount of more than 2 kinds of anti-depressants) or low treatment-tolerance (insufficient administration due to side-effects while taking more than 2 kinds of anti-depressants)
5) Satisfactory informed consent obtained from participant him/herself

[ For healthy control ]
1) Aged 20-80 years old
2) No history of any psychiatric disorders
3) Not having current serious medical illness
4) Satisfactory informed consent obtained from the participant him/herself

Exclude criteria

Rejection criteria common to both patients and healthy controls
1) Decisionally impaired individuals who has diminished capacity to understand the aim of the research
2) Physically impaired individuals who are not able to complete the experiments
3) Subjects who are contraindicated for the use of TMS and MRI
Having an implanted heart pace-maker
Having implanted cerebral (arteries) clips
Having implanted neural/nerve stimulators
Having implanted pumps
Having work experience in a metal industry or possibility of metal residues remaining in the body
Having metal-tattoos (including tattooed eye-lining)
Being pregnant, or having possibility of being pregnant
4) Subjects who are contraindicated for the use of TMS
Personal history of seizure disorder such as epileptic disorder
5) Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher
6)Those participating in other intervention studies

Related Information

• Primary Sponsor: Okamoto Yasumasa
• Secondary ID(s): UMIN000019481