Condition category
Nervous System Diseases
Date applied
25/04/2017
Date assigned
23/05/2017
Last edited
23/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cluster headaches are a type of headache which involves excruciating attacks of pain on one side of the head. They can affect people of any age, but tend to be more common in men and people over the age of 20. Attacks can be described as stabbing and of the most severe intensity “like a knife penetrating behind the eye”. Cluster headaches can be difficult to treat with 15-20% of patients not responding to drug treatment. The severity of pain and the frequency of attacks seriously degrade patients’ quality of life, justifying the consideration of other, more drastic therapies. Trans-nasal endoscopic vidian neurectomy is a surgical technique is a surgical technique which involves severing or removing the vidian nerve (a nerve in the head). The aim of this study is to find out whether this procedure is an effective treatment for long-term (chronic) cluster headaches.

Who can participate?
Adults who have been suffering from daily cluster headaches for three years.

What does the study involve?
All participants undergo a trans-nasal endoscopic vidian neurectomy while under general anesthesia (put to sleep). After this procedure, most patients can leave the hospital at the same day and without other discomforts except a feeling of fullness in the nose. At the start of the study and then one week and one, three and six months after the surgery, patients are interviewed and complete a questionnaire to find out if their symptoms have improved.

What are the possible benefits and risks of participating?
Participants nay benefit from an improvement to their cluster headache symtpoms. There is a risk of developing dry eyes, a dry nose or numbness in the palate (roof of the mouth).

Where is the study run from?
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Taiwan)

When is the study starting and how long is it expected to run for?
August 2011 to December 2016

Who is funding the study?
Investigator initiated and funded (Taiwan)

Who is the main contact?
Dr Shao-Cheng Liu
m871435@ndmctsgh.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shao-Cheng Liu

ORCID ID

http://orcid.org/0000-0001-9730-1798

Contact details

Taipei Tzu Chi Hospital
Buddhist Tzu Chi Medical Foundation
No.289
Jianguo Road
Xindian District
New Taipei City
23142
Taiwan
+886 2 8792 7192
m871435@ndmctsgh.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20170425-VN

Study information

Scientific title

Surgical role of vidian neurectomy in treating chronic cluster headache

Acronym

Study hypothesis

Precise vidian neurectomy (VN) with maximal preservation of SPG activity is both effective and safe in patients with chronic cluster headache with failed pharmacological management.

Ethics approval

Institutional Review Board of Buddhist Tzu Chi General Hospital-Taipei Branch

Study design

Single-centre non randomised interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic cluster headache

Intervention

All participants undergo a trans-nasal endoscopic vidian neurectomy with maximal preservation of spheno-palatine ganglion activity. This involves precisely nerve transect via an endoscopic trans-naasl approach and no cauterization was used over the distal stump of the vidian nerve to avoid thermal injury of spheno-palatine ganglion.

At baseline, one week, and one, three, six and twelve months post procedure, participants undergo a range of assessments to measure the change of their headache pattern, including mean attack frequency, mean attack intensity, and pain disability index, by patient interviews and medical tests.

Intervention type

Phase

Drug names

Primary outcome measures

Headache pattern is measured by patient interviews, to obtain the change of the mean attack frequency (numbers of attacks per week) and mean attack intensity (using the visual analogue scale (VAS)) at baseline, one week, and one, three, six and twelve months post procedure.

Secondary outcome measures

The degree participants’ daily lives disrupted by cluster headache is obtained by patient interviews and questionnaire: the pain disability index (PDI) at baseline, one week, and one, three, six and twelve months post procedure.

Overall trial start date

31/08/2011

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of CCH according to the criteria of International Classification of Headache Disorders 2nd edition (ICHD-II)
2. Duration of CH exceeding three years
3. Daily attacks
4. Resistance to more than two pharmacological prophylactic treatments with adequate trials including rizatriptan or other available drugs in Taiwan (verapamil, lithium or steroid)
5. Treatment by vidian neurectomy ranked as a precise cut, with follow-up exceeding one year
6. Aged 17 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

9

Participant exclusion criteria

Patients with cluster headache who show good response to pharmacological treatments.

Recruitment start date

01/03/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Taiwan

Trial participating centre

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
No.289, Jianguo Road Xindian District
New Taipei City
23142
Taiwan

Sponsor information

Organisation

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Sponsor details

No.289
Jianguo Road
Xindian District
New Taipei City
23142
Taiwan
+886 2 8792 7192
m871435@ndmctsgh.edu.tw

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a high-impact peer reviewed journal (such as Scientific Reports).

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Shao-Cheng Liu (m871435@ndmctsgh.edu.tw)

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes