The Effects of ECT and/or iTBS on Olfaction and Cognition in Patients With Depression

September 1, 2017 updated by: Dr. Roumen Milev, Queen's University

The Effects of Electroconvulsive Therapy (ECT) and/or Intermittent Theta Burst Stimulation (iTBS) on Olfaction and Cognition in Patients With Depression

The sense of smell and cognition are known to be closely associated with mood and emotional processes. However, despite the clear links between olfaction and cognitive processes with emotional states, research into the role of olfaction, cognition, and mood disorders has so far yielded variable results. This study proposes to investigate the ability to detect and identify odours and assess cognition in a group of patients with unipolar and bipolar depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated utilizing standard olfactory testing protocols using commercially available kits. Cognition will be evaluated utilizing standard cognitive test protocols in a functional magnetic resonance imaging protocol. The results will potentially shed light on the link between olfaction, cognition and mood disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research to date indicates that olfactory sensitivity and cognition are reduced in depressed patients. The data also suggest that higher order cognitive odour evaluation, measured via identification testing, is not altered in depression. Furthermore, research into the effect (if any) of treatment on olfactory performance (sensitivity and identification) has been sparse. Researchers have called for studies that examine olfactory sensitivity prior to psychiatric treatment and post-remission. To the best of our knowledge there has yet to be a study on the effect of electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments on the olfactory performance of patients with treatment refractory Major Depressive Disorder (MDD) and bipolar depression. ECT has been identified as today's most effective treatment for severe depression due to the remission rates, speed of response, and the completeness of remission. iTBS is a new remittent transcranial magnetic stimulation (rTMS) protocol that has gained more notoriety within the field for the speed of administration, effectiveness of the treatment, and speed of response. Unlike rTMS, TBS mimics the endogenous theta rhythms of the brain, which results in greater potency in inducing long-term potentiation of synaptic connections in the targeted brain regions. iTBS has been shown to be effective in treating mood disturbances, and increasing plasticity and inducing neurogenesis in patients. People with MDD often struggle with cognitive impairments such as decreased executive functioning, attention, concentration, speed of processing, and working memory. The brain areas associated with cognition, such as the prefrontal cortex and hippocampus are negatively affected by depression; studies have shown decreased volume, activity, and disturbed brain connectivity in those two areas. Currently, there is a lack of treatment options for improving cognition in depressed patients. The investigators are focussing on exploring the therapeutic potential of iTBS on cognition.The preliminary evidence from our study will add to scientists' understanding of the short and long term effects of iTBS treatment on the cognitive related areas in the brain through the use of fMRI. The investigators also hope our research will allow psychiatrists to deliver better care to patients with debilitating cognitive impairments associated with depression. Overall, a study examining the olfactory and cognitive performance of patients with treatment resistant MDD and bipolar depression, pre-ECT/iTBS, post-ECT/iTBS, and post-remission would yield valuable insight into the link between olfaction and mood disorders as well as cognition and mood disorders.

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients receiving iTBS or ECT at Providence Continuing Care Mental Health Services Site and healthy controls recruited from the Kingston Area. Patients may originate from a number of locations and clinics in the area but receive their treatment at Providence Care and have been referred to this location for such. Controls should be age and gender matched to participants and will be recruited from the Kingston region.

Description

Inclusion Criteria:

  • Signed Patient Informed Consent
  • Patients with MDD (DSM-IV-TR - criteria used) OR Patients with bipolar depression (DSM-IV-TR - criteria used)
  • Males or females over 18 years of age
  • In-patients or out-patients currently scheduled to receive ECT or rTMS

Exclusion Criteria:

  • Patients suffering from other neurological or endocrine disorders known to affect olfactory functioning.
  • Patients suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
  • Schizophrenia, Schizoaffective or other Psychotic Disorder
  • Patients over 65 years of age
  • Patients with significant allergies
  • Patients with environmental sensitivities (e.g. perfumes)
  • Patients with mechanical obstruction of the nasal passages (e.g. deviated septum)
  • Patients with congenital anosmia or other previous primary olfactory dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
Patients will be receiving either ECT or iTBS as a depression management. Olfactory functioning will be assessed at pre-treatment and 6 weeks later at post-treatment using Sniffin Sticks. Cognition will also be tested using Cognitive Function Imaging and Battery in the fMRI as well as Cognitive Batteries outside of the scanner at pre-treatment, 6 weeks later at post-treatment, and 3 months after the final treatment session.
Device: Cognitive Function Imaging and Battery
Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
Device: Sniffin Sticks
Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
Other: Cognitive Batteries
Participants will conduct the following cognitive batteries: DSST, TMT A & B, RAVLT
Control
Controls will have their olfactory functioning assessed at baseline and 6 weeks after the baseline assessment using Sniffin Sticks. Cognition will also be tested using Cognitive Function Imaging and Battery in the fMRI as well as Cognitive Batteries outside of the scanner at pre-treatment, 6 weeks later at post-treatment, and 3 months after the final treatment session.
Device: Cognitive Function Imaging and Battery
Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
Device: Sniffin Sticks
Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
Other: Cognitive Batteries
Participants will conduct the following cognitive batteries: DSST, TMT A & B, RAVLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Olfactory Function Change using Burghart's Sniffin' Sticks
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Cognitive Function Change using NBACK, Shopping List, and Symbol Span Tests
Time Frame: Baseline, 6 weeks, 3 months
Baseline, 6 weeks, 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant's Olfactory Identification using Sniffin' Sticks Identification Test
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Participant's Olfactory Threshold using Sniffin' Sticks Threshold Test
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Participant's Olfactory Discrimination using Sniffin' Sticks DiscriminationTest
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

Providence Healthcare

Investigators

  • Principal Investigator: Roumen V Milev, MD FRCPC, Queen's University Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6006093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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