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Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

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ClinicalTrials.gov Identifier: NCT03049969
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
The proposed study will test the feasibility and tolerability of transcranial direct current stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 60 cognitive remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to 4.0 mA, dorsolateral prefrontal cortex or montage dependent on specific area of deficit) while they complete the cognitive training tasks.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Neurological Disorder Device: tDCS stimulation Not Applicable

Detailed Description:
Transcranial Direct Current Stimulation (tDCS) is a novel, safe, well-tolerated, and low-cost treatment approach that may enhance the benefits of cognitive remediation. The application of tDCS is a relatively recent therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. To meet this study's objectives, investigators will focus specifically on working memory (WM) in both training and outcome. Limiting training to WM exercises will provide the opportunity to test proof of concept for the combined therapies within this shorter two-week time frame, and maximize the synergistic effect by engaging the same regions as targeted by the tDCS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Remediation
For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed.
Device: tDCS stimulation
up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
Other Name: Soterix Mini-CT




Primary Outcome Measures :
  1. Number of participants completing at least 80% of the targeted number of sessions. [ Time Frame: 1 Month ]
    The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step


Secondary Outcome Measures :
  1. Tolerability questionnaire [ Time Frame: 1 Month ]
    Administered by study staff (pre- and post-session)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • At least 18 years of age
  • Clinician Referral for cognitive remediation.
  • Have undergone a neurological examination and neuropsychological examination as part of standard of care.
  • Has access to internet service at home compatible with the study laptop (Wi-Fi or ethernet cable)
  • Able to commit to the designated period of study training sessions with baseline and follow-up visits.
  • Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

  • Visual, auditory and motor deficits that would prevent full ability to understand study instructions or operate the tDCS device or study laptop, as judged by treating clinician or study staff
  • Primary, uncontrolled psychiatric disorder that would influence ability to participate
  • Poorly controlled epilepsy
  • Medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
  • Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
  • Treatment for a communicable skin disorder currently or over the past 12 months
  • Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
  • Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score <85*
  • Symbol Digit Modalities Test (SDMT) ≥3.0 SD below published norms*
  • Learned English language after 12 years of age
  • Pregnant or breastfeeding

    • In the case of the potential participant having either speech, motor or vision impairment secondary to their condition that will limit the completion of the SDMT and WRAT-4 screening measures the substitutions as mentioned above will be used.

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): NCT03049969


Contacts
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Contact: Kathleen Sherman 646 501 7531 kathleen.sherman@nyumc.org
Contact: Kai Sherman 646 501 7531 kai.sherman@nyumc.org

Locations
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United States, New York
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Kathleen Sherman       kathleen.sherman@nyumc.org   
Principal Investigator: Leigh Charvet, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
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Principal Investigator: Leigh Charvet, MD New York University Medical Center Institutional Review Boards

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03049969     History of Changes
Other Study ID Numbers: 16-01810
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by New York University School of Medicine:
Working Memory
Cognitive Training
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
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Multiple Sclerosis
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases