To investigate the feasibility of a combination therapy (consisting of individualized rTMS and cognitive strategy training) and study measurements in patients with a primary brain tumor during stable disease. The study is considered feasible when 80…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of a combination therapy and study measurements in glioma patients.
Feasibility will be assessed by completed intervention and measurements: how
many of the included patients finish the intervention and obligatory
measurements at T1.
Secondary outcome
A set of exploratory parameters will be used to investigate the feasibility of
measurements aimed at assessing treatment effects in a future RCT. These
parameters consist of EMA examining objective and subjective cognitive
functioning along the whole study trajectory. Additionally, several
measurements will be performed at baseline, directly after and six months
after treatment, namely neuropsychological assessments, questionnaires for
subjective cognitive functioning, questionnaires concerning quality of life,
functioning, fatigue, and psychological wellbeing, neurological examination,
advanced neuroimaging and clinical parameters (tumor location, undergone
previous treatments, medication use) will be assessed. Additionally,
tolerability and side-effects of the rTMS treatment will be assessed.
Background summary
Up to 80% of glioma patients experience cognitive impairment. These cognitive
problems are associated with decreased functional independence and quality of
life. A combination therapy consisting of repetitive transcranial magnetic
stimulation (rTMS) and cognitive strategy training has potential to reduce
cognitive complaints in glioma patients.
Study objective
To investigate the feasibility of a combination therapy (consisting of
individualized rTMS and cognitive strategy training) and study measurements in
patients with a primary brain tumor during stable disease. The study is
considered feasible when 80% of the subjects finish the intervention and
obligatory measurements at T1.
Study design
This is a monocenter randomized feasibility study. Patients will be randomized
to one of the twotreatment arms: cognitive strategy training + active rTMS or
cognitive strategy training + sham rTMS treatment. Measurements will take place
at baseline, directly after and six months after treatment. Additionally,
around the intervention period patients will have short daily measurements
assessed by an app for a period of max. 12 weeks.
Intervention
Patients will receive 7 weeks of combined rTMS/sham + cognitive strategy
training (NRMP). 21 sessions of rTMS (3x times a week) and 7 weekly sessions of
cognitive strategy training will be given. All patients will receive treatment
at Amsterdam UMC location Vrije Universiteit Amsterdam. Besides the treatment
sessions in the hospital, patients are asked to do homework assignments for the
cognitive strategy training. rTMS will be provided by certified personnel and
cognitive strategy training will be given by trained psychologists.
Study burden and risks
Patients will receive 21 sessions of rTMS (30 minutes per session, 3 sessions a
week) concurrently to cognitive strategy training (60 minutes per session, 1
session a week). In total, the combination therapy will last for 7 weeks.
Assessments will take place before and directly after the treatment and will
take approxemately 3 hours. The obligatory measurements consist of
neuropsychological assessment, MRI at T0, questionnaires and a daily
measurement via an app on the mobile phone. 6 months after treatment there
will be a follow-up measurment consisting of a short neuropsychological
assessment and questionnaires. This measurement will approxemately take 2
hours.
Optional measurements are: MEG, MRI at T1 and neurological assessment
(approxemately 2,5 hours)
Both rTMS and cognitive strategy training are considered as safe treatments.
Potential risks are the possible rTMS-related side effects: TMS is considered
safe and generally tolerable. When following the international safety
guidelines (Rossi et al. 2021), the risk to induce an epileptic convulsion is
extremely low. Hearing protection is achieved by wearing ear plugs during
stimulation. There is a lot of experience with rTMS in psychiatric diseases in
our team (OA van den Heuvel) and from experience we know that adverse events,
or co-occurrences, during treatment in are rare, and consist mostly of
headache, local scalp pain and sleepiness. Frequency and severity of these
adverse events differs
widely between subjects, and has not led to subjects withdrawing from our
earlier trials.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
- >= 18 years of age
- Histological diagnosis of diffuse glioma (WHO grade 2,3, or 4)
- Subjective cognitive impairment, defined as CFQ-score >= 44
- Stable disease, i.e. no oncological treatment for <= 2 months prior to
inclusion; no radiological progression on the most recent MRI, not older than 6
months, and no clinical progression at inclusion
- Stable dosage (for at least 8 weeks) of anti-epileptic medication
Exclusion criteria
- Current pregnancy or have given birth less than three months ago
- Current other treatment for cognitive complaints
- Karnofsky performance score <70
- A diffuse glioma located in the parietal cortex
- TMS exclusion: implanted medical devices (e.g. pacemaker, deep brain
stimulator, cochlear implants, medical infusion device, etc.); metal in the
body; dose change in antiepileptic drugs in the last 8 weeks; use of
pro-convulsive drugs; substance misuse or withdrawal; sleep deprivation
- MRI exclusion: extreme claustrophobia or metallic objects in or on the body
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82233.018.23 |