- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07919587
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients (TMS and TBS)
Effect of Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in a Sample of Patients With Borderline Personality Disorder: A Randomized Controlled Trial
the goal of this randomized clinical trial is to evaluate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) in patients with borderline personality disorder (BPD). The study aims to assess whether these brain stimulation techniques can reduce symptoms of emotional dysregulation, impulsivity, and non-suicidal self-injury.
The main questions it aims to answer are:
Does high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC) improve emotional dysregulation, impulsivity, and non-suicidal self-injury in patients with BPD? Does intermittent theta-burst stimulation (iTBS) over the left DLPFC produce similar therapeutic effects? How does the efficacy of rTMS and iTBS compare to sham stimulation after completing the treatment course?
Participants will be randomly assigned to one of three groups:
- High-frequency rTMS group
- Intermittent theta-burst stimulation (iTBS) group
- Sham stimulation group Each participant will receive 15-20 stimulation sessions over the left DLPFC. Changes in emotional dysregulation, impulsivity, and non-suicidal self-injury symptoms will be evaluated before and after treatment.
연구 개요
상태
상세 설명
Borderline Personality Disorder (BPD) is a complex psychiatric condition characterized by emotional dysregulation, impulsivity, and recurrent non-suicidal self-injury (NSSI).
Although psychotherapy and pharmacological interventions remain the mainstay of treatment, many patients continue to experience severe emotional instability and impulsivity. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) have recently shown promise in modulating fronto-limbic circuits involved in emotion regulation.
This prospective, randomized, double-blind, controlled clinical trial aims to evaluate and compare the therapeutic efficacy of high-frequency rTMS and intermittent theta-burst stimulation (iTBS) applied over the left dorsolateral prefrontal cortex (DLPFC) in patients diagnosed with BPD. The interventions are expected to enhance prefrontal modulation of limbic activity, thereby improving emotional regulation, reducing impulsivity, and decreasing non-suicidal self-injury behaviors.
Participants will be randomly assigned to one of three groups:
Group 1: High-frequency rTMS (5 Hz, 1200 pulses/session, 80-110% RMT, 21 min total) Group 2: Intermittent theta-burst stimulation (iTBS, 50 Hz bursts, 600 pulses/session, 80-120% RMT, 21 min total) Group 3: Sham stimulation (matched duration and sound without magnetic output) All participants will continue their standard therapy for BPD, including weekly Dialectical Behavior Therapy (DBT) sessions during the study. Each participant will receive 20 sessions over 4 weeks (5 sessions per week). Allocation concealment will be ensured using sealed, numbered envelopes prepared by an independent administrator, and both participants and assessors will be blinded to group assignment.
Clinical assessments will include:
Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) for BPD diagnosis General Health Questionnaire (GHQ-28) to screen for psychiatric comorbidities Difficulties in Emotion Regulation Scale - Short Form (DERS-16) Barratt Impulsiveness Scale (BIS) Deliberate Self-Harm Inventory (DSHI) Measurements will be taken at baseline (pre-intervention) and after completion of the stimulation sessions (post-intervention).
Safety procedures will follow international TMS safety guidelines (Rossi et al., 2009; Lefaucheur et al., 2020). Adverse effects such as transient headache or scalp discomfort will be monitored, and any serious adverse events (e.g., seizures) will be immediately reported to the Research Ethics Committee.
This study seeks to determine whether rTMS or iTBS is more effective than sham stimulation in improving emotion regulation, reducing impulsivity, and decreasing self-harm behaviors. It will also explore whether iTBS, with its shorter session duration, provides a comparable or superior therapeutic benefit to conventional rTMS.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: dina h abouelleil, Masters of neuropsychiatry
- 전화번호: +201062229030
- 이메일: dinahussein@med.asu.edu.eg
연구 장소
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Cairo Governorate
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Cairo, Cairo Governorate, 이집트, 11252
- 모병
- Ainshams University Hospitals
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연락하다:
- dina h abouelleil, msc of neuropsychiatry
- 전화번호: +201062229030
- 이메일: Dinahussein@med.asu.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 1. Age range: 21-50 years old. 2. Gender: males and females 3. Borderline personality disorder diagnosis
Exclusion Criteria:
- 1. Presence of other uncontrolled mental illness that precludes the ability to provide informed consent (e.g.; acute psychosis, bipolar disorder currently in manic episode, major depressive disorder with recent suicidal attempt).
2. Patients with contraindications to TMS as cardiac patients with pacemakers, metallic implants as cochlear implants, aneurysm clips, stents, and deep brain stimulation electrodes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Repetitive Transcranial Magnetic Stimulation
Participants receive 15-20 sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC). Each session lasts approximately 21 minutes. |
rTMS will be delivered at 5 Hz frequency, 1200 pulses per session, at 80-110% of the individual's resting motor threshold (RMT). Stimulation will be applied to the left DLPFC (F3 according to the 10-20 EEG system) using a figure-of-eight coil. Each session includes 18 minutes of active stimulation followed by 3 minutes of sham stimulation on the target site. Sessions are administered 5 days per week for 4 weeks (total 20 sessions).
다른 이름들:
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활성 비교기: Intermittent Theta-Burst Stimulation Group
Participants receive 15-20 sessions of intermittent theta-burst stimulation (iTBS) over the left dorsolateral prefrontal cortex (DLPFC). Each session lasts approximately 21 minutes. |
iTBS will be delivered as 50 Hz bursts (three pulses per burst, 5 Hz bursts) at 80-120% of resting motor threshold, totaling 600 pulses per session. Stimulation will be applied over the left DLPFC (F3 site, 10-20 EEG system). Each session includes 3 minutes of active iTBS and 18 minutes of sham stimulation. Sessions are administered 5 days per week for 4 weeks (total 20 sessions).
다른 이름들:
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가짜 비교기: Sham Stimulation Group
Participants receive sham stimulation sessions identical in duration and sound to the active conditions but without active magnetic output. |
Sham stimulation will be delivered using the same coil orientation and acoustic cues as the active conditions, but with the magnetic field output disabled. Each session includes 18 minutes of sham rTMS and 3 minutes of sham TBS over the left DLPFC (F3 site). Sessions are administered 5 days per week for 4 weeks (total 20 sessions). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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improvement of impulsivity in BPD as assessed by barratt impulsivity scale (BIS)
기간: 20 sessions given over 1 month
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Improvement of results of The barratt impulsivity scale (BIS) measured before starting sessions and after finishing 20 sessions |
20 sessions given over 1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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improvement of emotional dysregulation as per Difficulties in Emotion Regulation Scale(DERS)
기간: 20 sessions1 month
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Improvement of results of DERS measured before starting sessions and after finishing 20 sessions |
20 sessions1 month
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improvement of non-suicidal self injury
기간: 20 sessions given in 1 month
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Improvement of results of The Deliberate Self-Harm Inventory (DSHI) measured before starting sessions and after finishing 20 sessions |
20 sessions given in 1 month
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공동 작업자 및 조사자
수사관
- 연구 책임자: mohamed F professor Dr, MD of psychiatry, ainshams university
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FMASU MD169/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
de-identified individual participant data will be available upon reasonable request after publication of the primary results
IPD 공유 기간
5 years after publication
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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