## Protocol Section
### Identification Module
**NCT ID:** NCT00316979

**Brief Title:** Efficacy of rTMS in the Treatment of Patients With Migraine

**Official Title:** Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Migraine Using Somatosensory Evoked High-Frequency Oscillations as a Parameter: A 3-year Study.

#### Organization Study ID Info
**ID:** rTMS_Migraine_VGHTPE
#### Organization
**Class:** OTHER_GOV
**Full Name:** Taipei Veterans General Hospital, Taiwan
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2010-06-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-06-06

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2006-04

**Status Verified Date:** 2010-06

#### Study First Post Date
**Date:** 2006-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2006-04-20
**Study First Submit QC Date:** 2006-04-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** National Science Council, Taiwan

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Taipei Veterans General Hospital, Taiwan

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of long-term potentiation or long-term depression. This study will will test the safety and efficacy of rTMS in the treatment of patients with Migraine.

### Conditions Module

**Conditions:**

- Migraine

**Keywords:**

- migraine

- transcranial magnetic stimulation

- repetitive transcranial magnetic stimulation

- rTMS

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Repetitive Transcranial Magnetic Stimulation (rTMS)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Reduction in days of migraine attack per month

#### Secondary Outcomes

**Measure:** The reduction in dosage of acute abortive medication

**Measure:** The reduction of headache index

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age of 18-65 years
* Diagnosed as migraine (with or without aura)
* More than 4 attacks per month for at least 3 months prior to study
* No preventive medication used
* Must be able to sign permit

Exclusion Criteria:

* History of seizure or family history of seizures
* Women in pregnancy or breast-feeding
* Patient with medication overuse
* Patient with other medical, psychologic, or surgical illness
* Patient under preventive medications
* Prior rTMS examination one month within

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sjwang@vghtpe.gov.tw

**Name:** Shuu-Jiun Wang, MD

**Phone:** +886-2-28712121

**Phone Ext:** 2425

**Role:** CONTACT

**Contact 2:**

**Email:** kllai@vghtpe.gov.tw

**Name:** Kuan-Lin Lai, MD

**Phone:** +886-2-28712121

**Phone Ext:** 3185

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taipei

**Contacts:**

***Contact 1:***

- **Email:** sjwang@vghtpe.gov.tw

- **Name:** Shuu-Jiun Wang, MD

- **Phone:** +886-2-28712121

- **Phone Ext:** 2425

- **Role:** CONTACT

***Contact 2:***

- **Email:** jlfuh@vghtpe.gov.tw

- **Name:** Jong-Ling Fuh, MD

- **Phone:** +886-2-28712121

- **Phone Ext:** 3256

- **Role:** CONTACT

***Contact 3:***

- **Name:** Shuu-Jiun Wang, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Taiwan

**Facility:** Headache Center, Teipei Veterans General Hospital

**Status:** RECRUITING

**Zip:** 112

#### Overall Officials

**Official 1:**

**Affiliation:** Headache Center, Taipei Veterans General Hospital

**Name:** Shuu-Jiun Wang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, Fierro B. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004 Dec 15;227(1):67-71. doi: 10.1016/j.jns.2004.08.008.

**PMID:** 15546593

**Citation:** Lorenz J, Minoshima S, Casey KL. Keeping pain out of mind: the role of the dorsolateral prefrontal cortex in pain modulation. Brain. 2003 May;126(Pt 5):1079-91. doi: 10.1093/brain/awg102.

**PMID:** 12690048

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2011-06-14

- Date Unknown: Unknown

#### Event: RESET

- Date: 2011-07-08

- Date Unknown: Unknown

#### Event: RELEASE

- Date: 2011-07-12

- Date Unknown: Unknown

#### Event: RESET

- Date: 2011-08-04

- Date Unknown: Unknown

#### Event: RELEASE

- Date: 2012-04-19

- Date Unknown: Unknown

#### Event: RESET

- Date: 2012-05-23

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M9351

- Name: Headache

- Relevance: LOW

- As Found: Unknown

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2011-06-14

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2011-06-14

- Reset Date: 2011-07-08

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- MCP Release N: Unknown

- Release Date: 2011-07-12

- Reset Date: 2011-08-04

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- MCP Release N: Unknown

- Release Date: 2012-04-19

- Reset Date: 2012-05-23

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
