Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03817593 |
| Other study ID # |
Sheba-18-5309-DG-CTIL |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2021 |
| Est. completion date |
May 24, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental
disorders experienced in childhood, with limited options for effective pharmacological
treatment. Transcendental Meditation (TM) has been proposed to be used as a tool for
attentional training and modulating autonomic nervous system activity in the ADHD population.
However, the empirical support in favor of meditation for ADHD is limited, and the mechanism
by which TM may have an effect on ADD/ADHD is not understood. There is also a conflicted data
as to the nature of autonomic dysregulation of ADHD.
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the
interbeat interval, and considered to be a non-invasive tool to study autonomic nervous
system. There is evidence that a non-directive meditation may increase parasympathetic
activity and overall HRV. To the best of our knowledge, the differential effect of meditation
on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not
been assessed.
The aim of this study is to collect the data on ADHD adolescents who will get TM training as
a part of out-of-school program, which is offered all children diagnosed with ADD/ADHD, aged
11.5 y-16y, in the community center of Kadima-Zoran, Israel.
The assessment of all of the children participating in this program will be performed with
the help of validated questionnaires for diagnosis and follow-up of ADD/ADHD, and HRV
monitoring.
In order to perform an assessment in a controlled way, the instruction of TM shall take place
in two cycles of 3 months each.
Description:
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental
disorders experienced in childhood, with a prevalence of 5 -10%, and can persist into
adulthood (1) It is characterized by a combination of overactive, poorly modulated behavior
with marked inattention and may involve physical aggression, which may be associated with a
number of structural and functional abnormalities in the central nervous system (2).
Pharmacological treatment is often the treatment of choice; however its effectiveness is
limited and often involves considerable side effects (3).
Meditation has been proposed to be used as a tool for attentional training and modulating
autonomic nervous system activity in the ADHD population. A systematic review of meditation-
based interventions for children with ADHD could not reach definite conclusions regarding
their efficacy due to poor methodological quality of the studies (4).
A pilot randomized controlled study published few years ago demonstrated that three months of
TM practice resulted in significant improvement of ADHD symptoms (5).
The mechanism by which TM may have an effect on ADD/ADHD is not understood. Furthermore, it
is not clear whether TM may have a differential effect on the two subclasses of this
condition: inattentive- and hyperactive- type
Individuals with ADHD probably have imbalances in autonomic nervous system activity, which
may be associated with impairment of sustained attention (6) and emotional regulation
(7,8,9).
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the
interbeat interval, resulting from dynamic balance of sympathetic and parasympathetic inputs
to the heart being a non-invasive tool to study autonomic nervous system, has been proposed
to be related to cognitive performance (10) and be a potential marker of stress (11). A lower
resting HRV has been associated with greater difficulties in emotional regulation, especially
a lack of emotional clarity and impulse control (12), depression and anxiety states (15),
while higher levels - with higher cognitive performance, increased emotional regulation and
perception of well-being (13, 14).
There is however no agreement as to the nature of autonomic dysregulation of ADHD (9,16,17).
The effect of meditation on autonomic nervous system via changes in heart rate variability
has been studied recently. Interestingly, some of the techniques were associated with lower
HRV (18), while others - with increased parasympathetic activity and HRV (19). To the best of
our knowledge, the differential effect of meditation on ADHD symptoms: according to the
baseline HRV of the participants, or ADHD subtypes has not been assessed.
Aims
Primary objective:
To collect the data on ADHD adolescents who will get TM training
Secondary objectives:
1. To assess whether improvement of symptoms may be sustained for 3 months after the
intervention.
2. To assess whether the effect of TM on ADHD symptoms may be correlated with the baseline
HRV or ADHD subtypes of the participants.
Participants and Methods
Study design TM classes are going to take place in the facility of Community Center at the
Kadima Zoran Community Center for Culture and Sport (as an out-of-school program): a group of
TM instructors will provide TM teaching to the adolescents with ADD/ADHD of the Zoran school,
with the consent of the teachers and the parents of the children.
Since March 2019, the TM classes will be offered to all children aged 11.5 y-16y, with a
confirmed diagnosis of ADD/ADHD, under supervision of the school teachers.
About 50 adolescents out of 60 adolescents, diagnosed with ADHD shall participate in this
program.
The assessment and follow-up on these children will be performed by pediatric neurologist and
HRV monitoring.
The instruction of TM shall be in two groups (of 20-30 children each). TM training for each
group shall be 3 months. The children in both groups shall be followed up for 6 months, and
assessed by the same parameters.
Participants:
About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at this school, are
expected to participate in this program.
A senior pediatric neurologist will examine the children, confirm the diagnosis, according to
the DSM 5 criteria, and shall obtain a written informed consent for the evaluation of the
children during this program.
Current pharmacological treatment, ADHD subtype (e.g. inattentive type, combined type or
mixed type) and the comorbidities will be documented.
Group 1
Two certified teachers of TM will teach these children according to the following protocol,
as previously described by Grosswald et al(20):
Each participant will have an individual instruction for 1 hour, followed by a course of 3
weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes,
twice a day, during 3 months, under the supervision of school teachers who will be instructed
in TM technique.
A group follow-up will be performed 10 days after a completion of the course, and then each
participant will receive personal meetings with TM instructor on a weekly basis during the
first month, and then twice a month.
After additional 3 months participants in this group will be examined again, to assess
sustainability of the effect.
Group 2 Following the completion of the first 3 months period, the second group will receive
TM training as above, and during the first 3 months this will be a reference (control) group.
Data analysis
The data will be analyzed according to the treatment groups. Similarly to the previous study
(20) the expected statistical power of 93%will be calculated for comparison of means (Student
T-test) .The assumed difference between groups is 0.1 and adopted Standard Deviation within
the groups is ±0.1 (20).
Additional observations will be assessed according to the baseline HRV (sympathetic or
parasympathetic predominance) and the ADHD subgroups (inattentive or hyperactive
predominance), while the two ADHD subgroups and two HRV subgroups will be assessed
independently with dichotomous outcomes. In the probable case that the two TM groups (A&B)
shall not be significantly different, both groups may br assessed as one cohort with n=50,
assuming dichotomous outcomes. This project may provide a preliminary assessment of the
impact of ADHD subtype and of baseline HRV on the differential effect of TM on ADHD symptoms.
