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Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia (IEMO)

Primary Purpose

Frontotemporal Dementia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Intranasal oxytocin
Saline Nasal Mist
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontotemporal Dementia focused on measuring Frontotemporal Dementia, emotion, oxytocin, fMRI

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients:

  • Ages 30-85
  • meet consensus criteria for probable behavioural variant FTD (bvFTD)

Controls:

  • Age and sex matched with patients
  • Mini-Mental State Exam (MMSE) scores >27

Exclusion Criteria:

Patients:

  • history of stroke
  • intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition
  • diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD
  • cognitive impairment that precludes comprehension of task instructions
  • contraindication to MRI scanning
  • severe language or memory deficits that preclude participation in the study visits and measures
  • females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
  • uncontrolled hypertension
  • bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
  • current use of prostaglandins

Controls:

  • history of stroke
  • intracranial haemorrhage or other medical or neurological disorder
  • diagnosis of bipolar disorder or schizophrenia
  • cognitive impairment that precludes comprehension of task instructions
  • contraindication to MRI scanning
  • severe language or memory deficits that preclude participation in the study visits and measures
  • females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
  • uncontrolled hypertension
  • bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
  • current use of prostaglandins

Sites / Locations

  • Parkwood Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intranasal Oxytocin

Saline Nasal Mist

Arm Description

Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3

Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3

Outcomes

Primary Outcome Measures

Functional magnetic resonance imaging (fMRI) BOLD signal
Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans

Secondary Outcome Measures

Cognitive and Emotional Task performance
Performance on standardized tasks of emotion processing and cognition

Full Information

First Posted
September 3, 2013
Last Updated
August 7, 2018
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01937013
Brief Title
Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
Acronym
IEMO
Official Title
Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 12, 2013 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
Detailed Description
Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses. The usual treatments for Frontotemporal dementia focus on reducing agitation and aggressive behaviours. However, these drugs do not help all patients who experience blunting of emotion and loss of empathy. This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia
Keywords
Frontotemporal Dementia, emotion, oxytocin, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Oxytocin
Arm Type
Experimental
Arm Description
Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3
Arm Title
Saline Nasal Mist
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3
Intervention Type
Drug
Intervention Name(s)
Intranasal oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3.
Intervention Type
Drug
Intervention Name(s)
Saline Nasal Mist
Other Intervention Name(s)
Placebo
Intervention Description
Participants will be randomized to receive placebo on either study visit 2 or 3.
Primary Outcome Measure Information:
Title
Functional magnetic resonance imaging (fMRI) BOLD signal
Description
Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Cognitive and Emotional Task performance
Description
Performance on standardized tasks of emotion processing and cognition
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients: Ages 30-85 meet consensus criteria for probable behavioural variant FTD (bvFTD) Controls: Age and sex matched with patients Mini-Mental State Exam (MMSE) scores >27 Exclusion Criteria: Patients: history of stroke intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD cognitive impairment that precludes comprehension of task instructions contraindication to MRI scanning severe language or memory deficits that preclude participation in the study visits and measures females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause). uncontrolled hypertension bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm) current use of prostaglandins Controls: history of stroke intracranial haemorrhage or other medical or neurological disorder diagnosis of bipolar disorder or schizophrenia cognitive impairment that precludes comprehension of task instructions contraindication to MRI scanning severe language or memory deficits that preclude participation in the study visits and measures females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause). uncontrolled hypertension bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm) current use of prostaglandins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Finger, M.D.
Organizational Affiliation
LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Mitchell, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkwood Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32963103
Citation
Oliver LD, Stewart C, Coleman K, Kryklywy JH, Bartha R, Mitchell DGV, Finger EC. Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study. Neurology. 2020 Nov 10;95(19):e2635-e2647. doi: 10.1212/WNL.0000000000010933. Epub 2020 Sep 22.
Results Reference
derived

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Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

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