Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Multiple Sclerosis Clinical Trial

Official title:

Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03049969
• Other study ID #: 16-01810
• Status: Terminated
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: March 26, 2023

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 26, 2023
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Nervous System Diseases
• Neurological Disorder

Intervention

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

Locations

Country	Name	City	State
United States	New York University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of Participants With Treatment Related Adverse Events		End of treatment (up to 12 weeks)
Secondary	Change in Visual Analogue Scale (VAS) for Pain Score	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.	Baseline, end of treatment (up to 12 weeks)
Secondary	Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)	This brief scale is comprised of 10 items measuring negative affect (e.g., upset, afraid). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The negative affect score is calculated by finding the sum of the 10 negative items. Scores range from 10 - 50. For the total negative score, a lower score indicates less of a negative affect.	Baseline, end of treatment (up to 12 weeks)
Secondary	Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)	This brief scale is comprised of 10 items measuring positive affect (e.g., excited, inspired). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The positive affect score is calculated by finding the sum of the 10 positive items. Scores range from 10 - 50. For the total positive score, a higher score indicates more of a positive affect.	Baseline, end of treatment (up to 12 weeks)
Secondary	Change in Symbol Digit Modalities Test (SDMT) Score	The SDMT is a cognitive processing speed test. Participants are given a key of nine symbol-digit pairs along with a sequence of symbols. They are then asked to use the key to match as many symbols in the sequence to their corresponding numbers as possible within 90 seconds. The score is the number of correctly coded items from 0-110 in 90 seconds. Lower scores indicate cognitive decline.	Baseline, end of treatment (up to 12 weeks)