Trial Outcomes & Findings for Stimulating Neural Activity to Improve Blood Flow and Reduce Amyloid: Path to Clinical Trials (NCT NCT03543878)

Last Updated: 2021-03-02

Results Overview

Feasibility of the Flicker intervention is defined as adherence to Flicker exposure, at home, for one hour per day for the duration of the intervention period (4 or 8 weeks). The percentages of completed sessions are presented here.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Week 8

Results posted on

2021-03-02

Participant Flow

Participants were recruited from the Emory Cognitive Neurology Clinic and the Emory Goizueta Alzheimer's Disease Research Center (ADRC), in Atlanta, Georgia. Participant enrollment began on November 16, 2018 and study follow up was completed on February 10, 2020.

Participant milestones

Participant milestones
Measure	Flicker/Flicker Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.	No Flicker/Flicker Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flicker/Flicker n=5 Participants Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.	No Flicker/Flicker n=5 Participants Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.	Total n=10 Participants Total of all reporting groups
Age, Continuous	72 years STANDARD_DEVIATION 8.15 • n=5 Participants	70.6 years STANDARD_DEVIATION 6.54 • n=5 Participants	71.3 years STANDARD_DEVIATION 7.01 • n=10 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=5 Participants	5 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=5 Participants	5 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=5 Participants	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Flicker/Flicker n=5 Participants Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.	No Flicker/Flicker n=5 Participants Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
Percentage of Adherence to Daily Device Use	95.55 percentage of adherence to treatment Standard Deviation 2.92	95.37 percentage of adherence to treatment Standard Deviation 4.72

PRIMARY outcome

Timeframe: Baseline

Population: Outcome Measure Description continued: Tolerability at the highest level of "10" was scored as 100. Maximum tolerated levels for visual alone, auditory alone, visual combined, and auditory combined were averaged for the Flicker/Flicker and No Flicker/Flicker groups.

Participants rated their tolerance to Flicker stimulation prior to the study intervention, using a 1 - 5 point Likert scale for each of the 10 levels of brightness (visual stimulation) and each of the 10 levels of loudness (auditory stimulation) after 60 seconds of stimulation at each level. A rating of 1 indicated stimulation "can be withstood and comfortable," 3 indicated stimulation is "tolerable, but not necessarily comfortable," and 5 indicated stimulation "cannot be withstood or is uncomfortable." Ratings of 1, 2, and 3 were considered tolerable. After determining tolerance for auditory and visual stimulation separately, participants were exposed to combined visual and auditory levels beginning one level above the participant's highest stimulation that received a rating of 3 or lower. Tolerability of brightness and loudness levels of combined auditory stimulation was assessed for 60 seconds. See Analysis Population Description for more details.

Outcome measures

Outcome measures
Measure	Flicker/Flicker n=10 Participants Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.	No Flicker/Flicker Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
Percentage of Maximum Tolerated Stimulation Visual alone	94 percentage of tolerated stimulation Standard Deviation 9.66	—
Percentage of Maximum Tolerated Stimulation Auditory alone	98 percentage of tolerated stimulation Standard Deviation 4.22	—
Percentage of Maximum Tolerated Stimulation Visual when combined with auditory	93 percentage of tolerated stimulation Standard Deviation 12.52	—
Percentage of Maximum Tolerated Stimulation Auditory when combined with visual	94 percentage of tolerated stimulation Standard Deviation 18.97	—

Adverse Events

Flicker/Flicker

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

No Flicker/Flicker

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flicker/Flicker n=5 participants at risk Participants receiving the Flicker exposure for the first 4 weeks of the study and the second four weeks of the study, for a total of 8 weeks of treatment.	No Flicker/Flicker n=5 participants at risk Participants receiving no exposure to Flicker for the first 4 weeks of the study and then receiving the Flicker exposure for the second four weeks of the study, for a total of 4 weeks of treatment.
General disorders Dizziness	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Ear and labyrinth disorders Tinnitus	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
General disorders Headache	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
General disorders Double vision	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Musculoskeletal and connective tissue disorders Leg, arm, joint pain	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Musculoskeletal and connective tissue disorders Back pain	40.0% 2/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Psychiatric disorders Depression	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
General disorders Rhinorrhea	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
General disorders Gastrointestinal problems	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Injury, poisoning and procedural complications Fall	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Injury, poisoning and procedural complications Dog bite	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin growth on neck	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).
Gastrointestinal disorders Hemorrhoids	20.0% 1/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).	0.00% 0/5 • Adverse events were collected during the time when participants were receiving the Flicker intervention (up until Week 8 for the Flicker/Flicker group and until Week 4 for the No Flicker/Flicker group).

Additional Information

Annabelle C. Singer, PhD

Georgia Institute of Technology

Phone: 510-501-9659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place