12 Month Open Extension of TNS for ADHD.
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, ADHD |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 8 - 13 |
| Updated: | 3/27/2019 |
| Start Date: | December 1, 2014 |
| End Date: | May 30, 2018 |
12 Month Open Extension Study of TNS for ADHD .
Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS
will be invited to continue in a 12-month extension study, designed to collect additional
data on long-term response and tolerability and to provide participants ongoing clinical
benefit from treatment.
will be invited to continue in a 12-month extension study, designed to collect additional
data on long-term response and tolerability and to provide participants ongoing clinical
benefit from treatment.
Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of
active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the
double-blind, were then invited into a 4-week open TNS trial. Participants who met positive
response criteria to active TNS, either during the original double-blind study or the
open-treatment followup, were invited to continue their TNS treatment in a 12-month open
extension phase.
Participants who continued in the 12-month extension returned for study visits every 3 months
to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline
line assessments in the 12-month extension are taken from the final visit of the preceding
active treatment trial, i.e. the visit at which positive response criteria were met.
active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the
double-blind, were then invited into a 4-week open TNS trial. Participants who met positive
response criteria to active TNS, either during the original double-blind study or the
open-treatment followup, were invited to continue their TNS treatment in a 12-month open
extension phase.
Participants who continued in the 12-month extension returned for study visits every 3 months
to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline
line assessments in the 12-month extension are taken from the final visit of the preceding
active treatment trial, i.e. the visit at which positive response criteria were met.
Inclusion Criteria:
- male and female children ages 8-13 with DSM-5 ADHD, and current presentation, as
determined by KSADS and clinical interview
- received active TNS therapy in a previous trial and demonstrated a CGI-I score <= 2.
- parents able and willing to monitor proper use of the TNS device and complete all
required rating scales
- parent and participants able to compete study rating scales and other measures in
English
Exclusion Criteria:
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