Trial Outcomes & Findings for Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation (NCT NCT01958437)

NCT ID: NCT01958437

Last Updated: 2018-08-31

Results Overview

1 active tDCS; 1 sham tDCS for each measure. Participants touched a screen (using a ELO 19" touchscreen monitor) to document the location of the landmark. The distance between the actual vs. selected location served as the dependent measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

Outcome assessed after each of 2 sessions (estimated within 1 week of each other)

Results posted on

2018-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitively Intact -Active Then Sham tDCS All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact - Sham Then Active All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI - Active Then Sham All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI - Sham Then Active All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
Overall Study STARTED	11	11	11	11
Overall Study COMPLETED	11	11	10	10
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitively Intact -Active Then Sham tDCS All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact - Sham Then Active All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI - Active Then Sham All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI - Sham Then Active All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
Overall Study Incidental MRI findings	0	0	1	1

Baseline Characteristics

Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitively Intact Older Adults n=22 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Patients With Mild Cognitive Impairment n=20 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Total n=42 Participants Total of all reporting groups
Age, Continuous	72.15 years STANDARD_DEVIATION 7.14 • n=5 Participants	69.5 years STANDARD_DEVIATION 6.55 • n=7 Participants	70.8 years STANDARD_DEVIATION 6.89 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome assessed after each of 2 sessions (estimated within 1 week of each other)

Population: Computer errors caused missing data for a subset (n=4) of participants; those data have simply been omitted from analyses below.

Outcome measures

Outcome measures
Measure	Cognitively Intact ACTIVE tDCS n=22 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI ACTIVE tDCS n=20 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact SHAM tDCS n=22 Participants all participants received sham in a randomized order	MCI SHAM tDCS n=20 Participants all participants received sham in a randomized order
Accuracy in Centimeters From Target Location for Allocentric	13.24 Centimeters (cm) Standard Deviation 3.96	15.38 Centimeters (cm) Standard Deviation 2.13	14.22 Centimeters (cm) Standard Deviation 2.78	15.03 Centimeters (cm) Standard Deviation 1.77

PRIMARY outcome

Timeframe: change between active and sham tDCS sessions (<1month)

Population: Participants from each group were excluded due to movement artifact that invalidated fMRI data.

BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS \> sham HD-tDCS). Activation maps thresholded at p\<.01 with minimum cluster size of 5 voxels.

Outcome measures

Outcome measures
Measure	Cognitively Intact ACTIVE tDCS n=19 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI ACTIVE tDCS n=19 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact SHAM tDCS n=19 Participants all participants received sham in a randomized order	MCI SHAM tDCS n=19 Participants all participants received sham in a randomized order
Hippocampal BOLD Signal During Task-based fMRI	.089 Percent signal change Standard Deviation .12	.037 Percent signal change Standard Deviation .123	.143 Percent signal change Standard Deviation .134	.107 Percent signal change Standard Deviation .117

PRIMARY outcome

Timeframe: change between active and sham tDCS sessions (<1month)

Population: Participants from each group were excluded due to movement artifact that invalidated fMRI data.

Change in resting state functional connectivity strength between active and sham tDCS sessions. Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.

Outcome measures

Outcome measures
Measure	Cognitively Intact ACTIVE tDCS n=20 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI ACTIVE tDCS n=18 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact SHAM tDCS n=20 Participants all participants received sham in a randomized order	MCI SHAM tDCS n=18 Participants all participants received sham in a randomized order
Dorsal Attention Network Connectivity During Resting-state fMRI	29.41 arbitrary units Standard Deviation 7.09	30.93 arbitrary units Standard Deviation 11.97	30.39 arbitrary units Standard Deviation 8.2	31.47 arbitrary units Standard Deviation 9.89

PRIMARY outcome

Timeframe: Outcome assessed after each of the 2 sessions

Population: Participants from each group were excluded due to movement artifact that invalidated fMRI data.

Number of turns correctly recalled for each egocentric environment

Outcome measures

Outcome measures
Measure	Cognitively Intact ACTIVE tDCS n=22 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI ACTIVE tDCS n=20 Participants All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact SHAM tDCS n=22 Participants all participants received sham in a randomized order	MCI SHAM tDCS n=20 Participants all participants received sham in a randomized order
Egocentric	9.05 Correct turns Standard Deviation 3.53	8.21 Correct turns Standard Deviation 3.08	9.85 Correct turns Standard Deviation 3.6	7.47 Correct turns Standard Deviation 2.53

Adverse Events

Cognitively Intact Active

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Cognitively Intact Sham

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

MCI Active

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

MCI Sham

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cognitively Intact Active n=21 participants at risk；n=22 participants at risk All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	Cognitively Intact Sham n=22 participants at risk All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI Active n=20 participants at risk All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).	MCI Sham n=20 participants at risk All participants received active and sham transcranial direct current stimulation (tDCS). Participants were randomized to order (i.e., half received active tDCS in the first session and sham in the second session; the other half received the opposite).
Skin and subcutaneous tissue disorders Side effect questionnaire	0.00% 0/21 • duration of each participant's study related activities (~2 weeks), with monitoring ending following the second tDCS session All participants completed a standardized side effect questionnaire after every tDCS session.	0.00% 0/22 • duration of each participant's study related activities (~2 weeks), with monitoring ending following the second tDCS session All participants completed a standardized side effect questionnaire after every tDCS session.	5.0% 1/20 • Number of events 1 • duration of each participant's study related activities (~2 weeks), with monitoring ending following the second tDCS session All participants completed a standardized side effect questionnaire after every tDCS session.	0.00% 0/20 • duration of each participant's study related activities (~2 weeks), with monitoring ending following the second tDCS session All participants completed a standardized side effect questionnaire after every tDCS session.

Additional Information

Dr. Benjamin Hampstead

VA Ann Arbor Healthcare System; University of Michigan

Phone: 7347639259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place