Investigating Drop Attacks

Functional Disorder Clinical Trial

Official title:

Developing a Psychological Understanding of Idiopathic Drop Attacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694769
• Other study ID #: CAHSS1710/03
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: March 2020
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this project is to better understand the experiences of people who have idiopathic drop attacks. These falls have no identified medical cause but can cause people injuries such as bruising, facial injuries and, in some cases, broken bones. It can also make them worry about having more falls, and the pain and embarrassment this would cause, and stop them from going out. There has been very little research in this area and there are currently no treatments.

In this study, ten people who experience idiopathic drop attacks will be interviewed at an outpatient clinic to understand more about them and the falls. They will be asked in particular about the period of time around when they started having the falls and whether there are aware of any triggers. Participants will also be asked to write accounts of these drop attacks, after they have happened, for a period of eight weeks. They will be asked to describe what they were thinking and feeling, and how they felt in themselves before and after the fall.

This information will allow the researcher to look at common experiences that people who experience these falls have. This understanding could help to identify whether a psychological approach to treatment could help individuals to manage and cope with this condition.

Description:

Design

In this exploratory qualitative study, neurology outpatients with ongoing Idiopathic Drop Attacks (IDAs) will undergo psychological assessment and complete written diaries for eight weeks. Throughout the study, participants will receive treatment as usual from a neurologist.

Procedure

Participants will be recruited from a neurology outpatient clinic at the Department of Clinical Neurosciences in Edinburgh where they will be approached by their consultant who will give them a participant information sheet. If they are interested in taking part, a meeting will be set up with the researcher to discuss the study further and obtain written informed consent.

Participants will then meet with the researcher to complete an initial psychological interview which will be audio recorded. This interview will follow a standard initial psychological interview structure and will aim to gain information about the person's experiences of IDAs, along with relevant personal and social history.

Following this initial interview, participants will be asked to record written accounts of any IDA, detailing their thoughts, physical arousal, feelings and behaviour, as close to the event as possible. They will be encouraged to record detailed accounts, outlining the period before, during and after the episode, in order to identify any potential triggers. They will be shown an example of a completed diary in order to help them to understand what they need to do. Participants will be asked to record such events over a period of eight weeks during which the researcher will contact them fortnightly to discuss any difficulties or concerns. If participants do not experience any drop attacks during this period, they will be asked if they want to continue recording diaries for an additional two to four weeks.

Following completion of this period, participants will meet again with the researcher to return the diaries and discuss any patterns noticed in the interview and diaries. The researcher will also answer any further questions that the participant has about the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18+

2. Idiopathic drop attacks occurring 6+ times per year

3. Having previously completed extensive investigation into possible cause of drop attacks

4. Able to provide informed consent

Exclusion Criteria:

1. Diagnosis which would provide an alternative explanation for drop attacks

2. Drop attacks due to malfunction of the lower limbs, changes in body or head posture, or vertigo.

Related Conditions & MeSH terms

• Functional Disorder
• Syncope

Intervention

Other:
• Semi-structured interview
One-hour interview with researcher
• Drop attack diary
Diary of any drop attacks experienced within an 8 week period

Locations

Country	Name	City	State
United Kingdom	Western General Hospital (NHS Lothian)	Edinburgh	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-structured assessment interview	This audio-recorded 60-minute interview will follow the format of an initial psychological assessment and will allow discussion of presenting problems and relevant personal and social history. This will allow potential predisposing and precipitating factors to be identified. Participants' experiences of IDAs will also be discussed, focussing on thoughts, feelings and behaviour before and after the episodes. The participants will also be asked about the impact that these have had on their everyday functioning.	One hour
Secondary	Drop attack diary	Participants will be asked to write an account of any IDAs. They will be shown an example diary and will also be given a prompt sheet, asking them to recall any triggers, feelings, physical arousal, thoughts and behaviour both directly before and after the episode. This diary will be completed by participants as close to the episode as possible	8 weeks