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Repetitive TMS & Cognitive Training in Adults With Schizophrenia (CrTMS)

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ClinicalTrials.gov Identifier: NCT03741751
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ginger E Nicol, Washington University School of Medicine

Brief Summary:

The proposed project aims to establish the feasibility and tolerability of delivering repetitive transcranial magnetic stimulant (rTMS) combined with computerized cognitive training in patients with Schizophrenia or Schizoaffective Disorder and cognitive difficulties.

The investigators will conduct a 2 week randomized controlled trial study evaluating computerized cognitive training combined with either active or sham rTMS on cognitive and functional outcomes in adults with Schizophrenia or Schizoaffective Disorder.


Condition or disease Intervention/treatment Phase
Schizophrenia Spectrum and Other Psychotic Disorders Cognitive Impairment Device: rTMS Behavioral: Computerized cognitive training Not Applicable

Detailed Description:

Schizophrenia affects approximately 1.1% of U.S adults per year and is among the most disabling psychiatric illnesses, due primarily to poor functioning related to cognitive dysfunction. Negative (e.g. flattened affect, limited speech output, lack of motivation) and cognitive symptoms (e.g. poor executive functioning, attention and working memory) are by far the leading cause of social, occupational and educational disability and functional impairment in patients with schizophrenia. Since the advent of antipsychotic medications, Schizophrenia treatment has improved significantly with respect to positive symptom control. However, there are limited resources for improving cognitive symptoms in Schizophrenia, which remain disabling for most with the diagnosis. Cognitive remediation and cognitive training programs have shown promise in improving these symptoms. Specifically, adults with Schizophrenia show significant improvements in cognition after participating in 2 weeks of computer based cognitive training. Functional capacity has also been shown to improve with longer periods of computer-based cognitive training. However, the effects of cognitive training alone may be most effective in the short-term. Longer term effectiveness of cognitive training has yet to be shown.

There has been emergent interest in using neuromodulation for treatment of cognitive decline in people with various illnesses including children with ADHD, adults with schizophrenia and older adults with late life depression. Specifically, high frequency (20Hz) rTMS applied to the dorsolateral prefrontal cortex (DLPFC) bilaterally has been shown to improve working memory in patients with schizophrenia. By improving neuroplasticity and working memory, rTMS could significantly improve effects of cognitive training in patients with schizophrenia. Combination cognitive training and rTMS treatment has been used in patients with depression with promising results. Previously, the implementation of cognitive training programs in clinical settings was challenged by the intensity of required patient engagement. However, our group and others have applied computerized training programming that is accessible remotely, improving accessibility and engagement. Thus, computerized training offers a feasible and scalable combination with neuromodulation treatment. Here, we propose to test rTMS, in combination with a computerized cognitive training program, to remediate cognitive dysfunction in Schizophrenia and Schizoaffective Disorder in a pilot randomized clinical trial.

Aim: Conduct a randomized pilot and feasibility study of active versus sham rTMS combined with computerized cognitive training program in adults with Schizophrenia or Schizophreniform Disorders, comparing neurocognitive and functional outcomes between groups.

1a) the investigators hypothesize favorable differences between groups in acute improvement on neuropsychological executive functioning, as measured by the Screen for Cognitive Impairment in Psychiatry (SCIP).

1b) The investigators hypothesize favorable differences between groups in daily functioning as measured by the Canadian Objective Assessment of Life Skills (COALS) and the WHO Disability Assessment Schedule (WHODAS) in participants receiving CrTMS compared to controls.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Single (Participant)
Masking Description: participants will be masked to the TMS versus sham treatment. Sham treatment will be very similar to active TMS without the active magnetic stimulation
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation and Cognitive Training for Treatment of Cognitive Problems in Adults With Schizophrenia: A Pilot Randomized Trial
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: active rTMS with computerized cognitive training
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
Device: rTMS
Participants will receive either active or sham bilateral rTMS over the dorsolateral prefrontal cortex (DLPFC) for 12.5 min per side.
Other Name: High frequency repetitive transcranial magnetic stimulation

Behavioral: Computerized cognitive training
All participants will receive computerized cognitive training for 40 min after each rTMS session.

Sham Comparator: sham rTMS with computerized cognitive training
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
Behavioral: Computerized cognitive training
All participants will receive computerized cognitive training for 40 min after each rTMS session.




Primary Outcome Measures :
  1. Differences between groups on neuropsychological functioning [ Time Frame: 2 weeks ]
    Evaluate differences in neuropsychological functioning between active and sham rTMS groups using the Screen for Cognitive Impairment in Psychiatry (SCIP).


Secondary Outcome Measures :
  1. Differences between groups on life skills [ Time Frame: 2 weeks ]
    Evaluate differences in daily functioning between active and sham rTMS groups using the Canadian Objective Assessment of Life Skills (COALS).

  2. Differences between groups on disability [ Time Frame: 2 weeks ]
    Evaluate differences in daily functioning between active and sham rTMS groups using the WHO Disability Assessment Schedule (WHODAS).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Psychotic symptoms are stable

Exclusion Criteria:

  • Active substance use
  • History of seizures or seizure disorder
  • Active psychosis or recent psychiatric hospitalization
  • Use of medications that could impair cognitive functioning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741751


Contacts
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Contact: Rita Haddad, MD 314-362-5154 haddad@wustl.edu
Contact: Julia Schweiger 314-362-5154 schweigj@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rita Haddad, MD    314-362-5154    rhaddad@wustl.edu   
Contact: Julia Schweiger, CCRC    (314) 352-5154    schweigj@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine

Publications:

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Responsible Party: Ginger E Nicol, Associate professor of psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03741751     History of Changes
Other Study ID Numbers: 201808164
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ginger E Nicol, Washington University School of Medicine:
cognition
schizophrenia
schizoaffective disorder

Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Cognition Disorders
Neurocognitive Disorders