Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

NCT ID: NCT06422559

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-01-01

Brief Summary

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The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression

Detailed Description

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We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with unipolar depression

Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

Group Type EXPERIMENTAL

Transmagnetic stimulation

Intervention Type DEVICE

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

TMS

Intervention Type DEVICE

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Participants with bipolar depression

Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

Group Type EXPERIMENTAL

Transmagnetic stimulation

Intervention Type DEVICE

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

TMS

Intervention Type DEVICE

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Interventions

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Transmagnetic stimulation

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Intervention Type DEVICE

TMS

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age:18\_65 years
* Sex:male and female
* Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5
* No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle
* Pharmacological resistance

Exclusion Criteria

* Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder
* Patients complaining of epilepsy
* pregnancy and breastfeeding
* peacemaker spinal or bladder stimulator
* History of skull surgery and trauma
* presence of metallic foreign body
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hala A. El-boraie

Role: STUDY_CHAIR

Professor

Ibrahim H. Rashed

Role: STUDY_DIRECTOR

Assistant professor

Hassan M. Sonbol

Role: STUDY_DIRECTOR

Lecturer

Locations

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Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Shaimaa E. Mohamed

Role: CONTACT

Egypt 01014947026

Warda F. Aboelez

Role: CONTACT

01018186408

Facility Contacts

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Institutional R. Board

Role: primary

Egypt +2050-2202773:2202746

Warda F. Aboelez

Role: backup

01018186408

References

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Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. Maintenance treatment of transcranial magnetic stimulation (TMS) for treatment-resistant depression patients responding to acute TMS treatment. Int J Physiol Pathophysiol Pharmacol. 2020 Oct 15;12(5):128-133. eCollection 2020.

Reference Type BACKGROUND
PMID: 33224435 (View on PubMed)

Related Links

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Other Identifiers

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MD.22.12.731

Identifier Type: -

Identifier Source: org_study_id

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