Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

NCT03049969 | Terminated Results FDA Device

• 1 other identifier: 16-01810
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Neurological Disorder

Keywords

Working Memory; Cognitive Training; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

  End of treatment (up to 12 weeks)

• Number of Participants With Treatment Related Adverse Events

  End of treatment (up to 12 weeks)

Secondary Outcomes (4)

• Change in Visual Analogue Scale (VAS) for Pain Score

  Baseline, end of treatment (up to 12 weeks)

• Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)

  Baseline, end of treatment (up to 12 weeks)

• Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)

  Baseline, end of treatment (up to 12 weeks)

• Change in Symbol Digit Modalities Test (SDMT) Score

  Baseline, end of treatment (up to 12 weeks)

Study Arms (1)

Cognitive Remediation

EXPERIMENTAL

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

Interventions

tDCS stimulation DEVICE

up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks

Also known as: Soterix Mini-CT

Cognitive Remediation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 30890162 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Nervous System Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Leigh Charvet, MD
• Organization: NYU Langone Health

Leigh.Charvet@nyulangone.org

9294555141

Study Officials

• Leigh Charvet, MD

  New York University Medical Center Institutional Review Boards

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: February 7, 2017
• Primary Completion: March 26, 2023
• Study Completion: March 26, 2023
• Last Updated: July 9, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-06

Locations

US (1)