Investigating Drop Attacks

NCT03694769 | Completed

• 1 other identifier: CAHSS1710/03
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Disorder

Keywords

functional neurological symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Drop attack diary

  8 weeks

Study Arms (1)

All participants

Semi-structured interview and drop attack diary

Other: Semi-structured interview; Other: Drop attack diary

Interventions

Semi-structured interview OTHER

One-hour interview with researcher

All participants

Drop attack diary OTHER

Diary of any drop attacks experienced within an 8 week period

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a single functional neurological disorders clinic at the Western General Hospital in Edinburgh.

You may qualify if:

• Aged 18+
• Idiopathic drop attacks occurring 6+ times per year
• Having previously completed extensive investigation into possible cause of drop attacks
• Able to provide informed consent

You may not qualify if:

• Diagnosis which would provide an alternative explanation for drop attacks
• Drop attacks due to malfunction of the lower limbs, changes in body or head posture, or vertigo.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Western General Hospital (NHS Lothian)

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: July 20, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)