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Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Primary Purpose

Multiple Sclerosis, Neurological Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

tDCS stimulation

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Working Memory, Cognitive Training, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

New York University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Remediation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerability questionnaire

Administered by study staff (pre- and post-session)

Full Information

NCT ID

NCT03049969

First Posted

February 8, 2017

Last Updated

April 19, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03049969

Brief Title

Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Official Title

Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

February 7, 2017 (Actual)

Primary Completion Date

March 26, 2023 (Actual)

Study Completion Date

March 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Neurological Disorder

Keywords

Working Memory, Cognitive Training, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Remediation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

tDCS stimulation

Other Intervention Name(s)

Soterix Mini-CT

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants completing at least 80% of the targeted number of sessions.

Description

The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step

Time Frame

1 Month

Secondary Outcome Measure Information:

Title

Tolerability questionnaire

Description

Administered by study staff (pre- and post-session)

Time Frame

1 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leigh Charvet, MD

Organizational Affiliation

New York University Medical Center Institutional Review Boards

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30890162

Citation

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.

Results Reference

derived

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Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

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