Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Neurological Disorder
• Intervention / Treatment: Device: tDCS stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen Sherman; Phone Number: 646 501 7531; Email: kathleen.sherman@nyumc.org
• Study Contact Backup: Name: Matthew Lustberg; Phone Number: 646 501 7531; Email: matthew.lustberg@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Soterix Mini-CT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability questionnaire	Administered by study staff (pre- and post-session)	1 Month

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Leigh Charvet, MD, New York University Medical Center Institutional Review Boards

Publications and helpful links

General Publications

• Pilloni G, Shaw M, Feinberg C, Clayton A, Palmeri M, Datta A, Charvet LE. Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report. J Neuroeng Rehabil. 2019 Mar 19;16(1):41. doi: 10.1186/s12984-019-0514-z.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; Cognitive Training; Working Memory
• Additional Relevant MeSH Terms: Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Nervous System Diseases
• Other Study ID Numbers: 16-01810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No