Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

October 10, 2024 updated by: Jakub Antczak

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of conventional repetitive transcranial magnetic stimulation (rTMS) with documented noninferiority in improving mood in depressive disorders. The effect of both modalities on other significant depression symptoms has not been studied. In this feasibility study investigators aim primarily to assess the safety and therapeutic potential of iTBS over the left dorsolateral prefrontal cortex (lDLPFC) and cTBS over the right dorsolateral prefrontal cortex (rDLPFC) on sleep quality, sleep propensity, fatigue, and daytime sleepiness in patients with major and bipolar depression.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
  • Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).
  • The score of the Athens Insomnia Scale five or more
  • Unchanged antidepressive pharmacotherapy at least one month prior to inclusion

Exclusion Criteria:

  • Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
  • Psychotic symptoms at the time of inclusion
  • Suicidal ideations and/or attempts within three months prior to inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iTBS over the left DLPFC
Active iTBS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 magnetic pulses will be elicited.
Device: iTBS
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
Experimental: cTBS over the right DLPFC
Active cTBS with intensity of 120% of the resting motor threshold recorded from the left first dorsal interosseus will be administered over the right DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 1200 magnetic pulses will be elicited.
Device: cTBS
Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
Sham Comparator: Sham stimulation
Active iTBS or cTBS will be administered over the left or right DLPFC respectively with sham coil. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 or 1200 magnetic pulses will be elicited.
Device: Sham
Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory 2
Time Frame: Before intervention - four weeks after finishing intervention.
Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Before intervention - four weeks after finishing intervention.
Pittsburgh Sleep Quality Index
Time Frame: Before intervention - four weeks after finishing intervention.
Pittsburgh Sleep Quality Index is a questionnaire to identify sleep disturbances. It consists of a combination of Likert-type and open-ended questions, which are later converted to scaled scores. Scores for each question range from 0 to 3, with higher scores indicating greater sleep disturbances. The minimum value of the total score is 0 and the maximum is 21 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Before intervention - four weeks after finishing intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: Before intervention - four weeks after finishing intervention.
An eight-item scale. Each item refers to a situation such as driving a car or sitting quietly. The subject is asked to assess the chance of dosing in each situation, ranging from 0 (no chance) to 3 (dosing very likely). The minimum value of the total score is 0 and the maximum is 24 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Before intervention - four weeks after finishing intervention.
Brief Psychiatric Rating Scale
Time Frame: Before intervention - four weeks after finishing intervention.
An 18-item scale assessing negative symptoms, such as emotional withdrawal (e.g. withdrawal from relations), motor slowness and blunted affect. Each item is rated from 1 to 7 with 7-point Likert scaling, where 7 means the most severe disturbance. The minimum value of the total score is 18 and the maximum is 126 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Before intervention - four weeks after finishing intervention.
Fatigue Assessment Scale
Time Frame: Before intervention - four weeks after finishing intervention.
A 10-item scale to assess the severity of fatigue. Each item is an expression describing the fatigue, such as: "I am bored by fatigue" or "Mentally I feel exhausted". Each item is answered using a Likert-type scale ranging from 1 (never) to 5 (always). The minimum value of the total score is 10 and the maximum is 50 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Before intervention - four weeks after finishing intervention.
Quality of Life in Depression Scale
Time Frame: Before intervention - four weeks after finishing intervention.
A 34-item, self-reported scale to assess the impact of depression on the quality of life. The scale is scored binomially with higher scores indicating a lower quality of life. The minimum value of the total score is 0 and the maximum is 34 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Before intervention - four weeks after finishing intervention.
Sleep propensity non-rapid eye movement 1 sleep stage
Time Frame: Through study completion, an average of 1 year
A 23-channel electroencephalography (EEG), 2-channel electrooculogram (EOG) and a chin electromyogram (EMG) recorded through 45 minutes in lying position with eyes closed. The recordings will then be divided into 30 second epochs. Each epoch will be assigned to particular sleep stage or wake, according to standards of sleep staging issued by the American Academy of Sleep Medicine [Silber et al. 2007]. The difference in the latency of non-rapid eye movement 1 sleep stage (the time from light off to the first epoch of the non-rapid eye movement 1 sleep stage) before and after intervention will be assessed.
Through study completion, an average of 1 year
Sleep propensity non-rapid eye movement 2 sleep stage
Time Frame: Through study completion, an average of 1 year
A 23-channel electroencephalography (EEG), 2-channel electrooculogram (EOG) and a chin electromyogram (EMG) recorded through 45 minutes in lying position with eyes closed. The recordings will then be divided into 30 second epochs. Each epoch will be assigned to particular sleep stage or wake, according to standards of sleep staging issued by the American Academy of Sleep Medicine [Silber et al. 2007]. The difference in the latency of non-rapid eye movement 2 sleep stage (the time from light off to the first epoch of the non-rapid eye movement 2 sleep stage) before and after intervention will be assessed.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jakub Antczak

Collaborators

Institute of Psychiatry and Neurology, Warsaw

Investigators

  • Principal Investigator: Bogdan Stefanowski, MD, Institute of Psychiatry and Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JagiellonianU73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

EEG, EOG, EMG recordings, scans of scales, inventories and questionnaires will be available upon request sent per e-mail to: bstefanowski@ipin.edu.pl

IPD Sharing Time Frame

December 2026 - December 2030

IPD Sharing Access Criteria

For researchers in medical sciences and medical professional upon justification of their request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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