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

NCT06371352 | Recruiting

• 1 other identifier: JagiellonianU73
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unipolar Depression; Bipolar Disorder

Keywords

Unipolar Depression; Bipolar Disorder; theta burst stimulation; sleep; sleepiness; fatigue; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Beck Depression Inventory 2

  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

  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 Outcomes (6)

• Brief Psychiatric Rating Scale

  Before intervention - four weeks after finishing intervention.

• Epworth Sleepiness Scale

  Before intervention - four weeks after finishing intervention.

• Fatigue Assessment Scale

  Before intervention - four weeks after finishing intervention.

• Quality of Life in Depression Scale

  Before intervention - four weeks after finishing intervention.

• Sleep propensity non-rapid eye movement 1 sleep stage

  Through study completion, an average of 1 year

Study Arms (3)

iTBS over the left DLPFC

ACTIVE COMPARATOR

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

cTBS over the right DLPFC

EXPERIMENTAL

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

Sham stimulation

SHAM COMPARATOR

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

Interventions

iTBS DEVICE

Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.

iTBS over the left DLPFC

cTBS DEVICE

Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.

cTBS over the right DLPFC

Sham DEVICE

Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy

Sponsors & Collaborators

• Jakub Antczak: lead
• Institute of Psychiatry and Neurology, Warsaw: collaborator

Study Sites (1)

Institute of Psychiatry and Neurology

Warsaw, 02957, Poland

RECRUITING

Related Publications (1)

• Silber MH, Ancoli-Israel S, Bonnet MH, Chokroverty S, Grigg-Damberger MM, Hirshkowitz M, Kapen S, Keenan SA, Kryger MH, Penzel T, Pressman MR, Iber C. The visual scoring of sleep in adults. J Clin Sleep Med. 2007 Mar 15;3(2):121-31.

  PMID: 17557422 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder; Sleepiness; Fatigue

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bogdan Stefanowski, MD

  Institute of Psychiatry and Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bogdan Stefanowski, MD

CONTACT

+48 22 45 82 532; bstefanowski@ipin.edu.pl

Jakub Antczak, MD

CONTACT

+48 12 400 25 50; jakub.antczak@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo intervention will be delivered with a sham-coil for magnetic stimulation, which looks identical and elicits similar sounds as the coil used for active stimulation, but induces only negligible magnetic field.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Prospective, randomized, sham-controlled clinical trial in parallel design

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 17, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: December 2026 - December 2030
• Access Criteria: For researchers in medical sciences and medical professional upon justification of their request.

Locations

PL (1)