Trial Outcomes & Findings for tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis (NCT NCT02538094)

Last Updated: 2020-04-06

Results Overview

Change in performance on an individual cognitive test measure raw score from the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery tests (i.e. Paced Auditory Serial Addition Test scores). Change scores range from -120 to + 120. Positive change scores reflect improvement at the end of the intervention relative to baseline. Negative change scores reflect decline at the end of the intervention relative to baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Assessed at beginning and end of a 5-day treatment week

Results posted on

2020-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Sham tDCS First Participants received sham tDCS first and then active anodal tDCS after washout.	Active Anodal tDCS First Participants received active anodal tDCS first and then sham tDCS after washout.
Intervention 1 (5 Days Per Participant) STARTED	2	5
Intervention 1 (5 Days Per Participant) COMPLETED	2	4
Intervention 1 (5 Days Per Participant) NOT COMPLETED	0	1
Washout (4 Weeks) STARTED	2	4
Washout (4 Weeks) COMPLETED	2	3
Washout (4 Weeks) NOT COMPLETED	0	1
Intervention 2 (5 Days Per Participant) STARTED	2	3
Intervention 2 (5 Days Per Participant) COMPLETED	2	3
Intervention 2 (5 Days Per Participant) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham tDCS First Participants received sham tDCS first and then active anodal tDCS after washout.	Active Anodal tDCS First Participants received active anodal tDCS first and then sham tDCS after washout.
Intervention 1 (5 Days Per Participant) Withdrawal by Subject	0	1
Washout (4 Weeks) Withdrawal by Subject	0	1

Baseline Characteristics

tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=7 Participants Transcranial direct current stimulation using Anodal stimulation over the area of interest or sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.29 years STANDARD_DEVIATION 11.16 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants
Paced Auditory Serial Addition Test	76.29 score on a scale STANDARD_DEVIATION 25.21 • n=5 Participants
Multidimensional Fatigue Symptom Inventory 30-item short form score	55.43 score on a scale STANDARD_DEVIATION 23.06 • n=5 Participants

PRIMARY outcome

Timeframe: Assessed at beginning and end of a 5-day treatment week

Outcome measures

Outcome measures
Measure	Sham tDCS n=5 Participants Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.	Active Anodal tDCS n=6 Participants Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.
Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores	-1.20 score on a scale Standard Deviation 6.26	-0.33 score on a scale Standard Deviation 9.42

SECONDARY outcome

Timeframe: Assessed at beginning and end of a 5-day treatment week

Fatigue was measured via changes in self-reported fatigue on the Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) total score over the course of active and sham tDCS. Change scores range from -84 to + 84. Positive change values reflect increased symptom burden at the end of the intervention relative to baseline. Negative change scores reflect reduced symptom burden at the end of the intervention relative to baseline.

Outcome measures

Outcome measures
Measure	Sham tDCS n=5 Participants Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.	Active Anodal tDCS n=6 Participants Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.
Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores	-7.40 score on a scale Standard Deviation 8.08	-15.0 score on a scale Standard Deviation 18.23

Adverse Events

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Anodal tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tracy Vannorsdall

Johns Hopkins University SOM

Phone: 4105023701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place