Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

NCT ID: NCT03049969

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2023-03-26

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.

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.

Conditions

Multiple Sclerosis; Neurological Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

tDCS stimulation

Intervention Type: DEVICE

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

Interventions

tDCS stimulation

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

Intervention Type: DEVICE

Other Intervention Names

Soterix Mini-CT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Charvet, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical Center Institutional Review Boards

Locations

New York University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30890162 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-01810

Identifier Type: -

Identifier Source: org_study_id